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Prosthesis
Prosthesis
from Wikipedia
A factory worker with a prosthetic arm using a lathe to produce artificial limbs c. 1944

In medicine, a prosthesis (pl.: prostheses; from Ancient Greek: πρόσθεσις, romanizedprósthesis, lit.'addition, application, attachment'),[1] or a prosthetic implant,[2][3] is an artificial device that replaces a missing body part, which may be lost through physical trauma, disease, or a condition present at birth (congenital disorder). Prostheses may restore the normal functions of the missing body part,[4] or may perform a cosmetic function.

A person who has undergone an amputation is sometimes referred to as an amputee, however, this term may be offensive.[5] Rehabilitation for someone with an amputation is primarily coordinated by a physiatrist as part of an inter-disciplinary team consisting of physiatrists, prosthetists, nurses, physical therapists, and occupational therapists.[6] Prostheses can be created by hand or with computer-aided design (CAD), a software interface that helps creators design and analyze the creation with computer-generated 2-D and 3-D graphics as well as analysis and optimization tools.[7]

Types

[edit]

A person's prosthetic device should be designed and assembled to meet their individual appearance and functional needs. Depending on personal circumstances, co-morbidities, budget or health insurance coverage, and access to medical care, decisions may need to balance aesthetics and function. In addition, for some individuals, a myoelectric device, a body-powered device, or an activity-specific device may be appropriate options. The person's future goals and vocational aspirations and potential capabilities may help them choose between one or more devices.[citation needed]

Craniofacial prostheses include intra-oral and extra-oral prostheses. Extra-oral prostheses are further divided into hemifacial, auricular (ear), nasal, orbital and ocular. Intra-oral prostheses include dental prostheses, such as dentures, obturators, and dental implants.

Prostheses of the neck include larynx substitutes, trachea and upper esophageal replacements,

Some prostheses of the torso include breast prostheses which may be either single or bilateral, full breast devices or nipple prostheses.

Penile prostheses are used to treat erectile dysfunction, perform phalloplasty procedures in men, and to build a new penis in female-to-male gender reassignment surgeries.

Limb prostheses

[edit]

Limb prostheses include both upper- and lower-extremity prostheses.

Upper-extremity prostheses are used at varying levels of amputation: forequarter, shoulder disarticulation, transhumeral prosthesis, elbow disarticulation, transradial prosthesis, wrist disarticulation, full hand, partial hand, finger, partial finger. A transradial prosthesis is an artificial limb that replaces an arm missing below the elbow.

An example of two upper-extremity prosthetics, one body-powered (right arm), and another myoelectric (left arm)

Upper limb prostheses can be categorized in three main categories: Passive devices, Body Powered devices, and Externally Powered (myoelectric) devices. Passive devices can either be passive hands, mainly used for cosmetic purposes, or passive tools, mainly used for specific activities (e.g. leisure or vocational). An extensive overview and classification of passive devices can be found in a literature review by Maat et.al.[8] A passive device can be static, meaning the device has no movable parts, or it can be adjustable, meaning its configuration can be adjusted (e.g. adjustable hand opening). Despite the absence of active grasping, passive devices are very useful in bimanual tasks that require fixation or support of an object, or for gesticulation in social interaction. According to scientific data a third of the upper limb amputees worldwide use a passive prosthetic hand.[8] Body Powered or cable-operated limbs work by attaching a harness and cable around the opposite shoulder of the damaged arm. A recent body-powered approach has explored the utilization of the user's breathing to power and control the prosthetic hand to help eliminate actuation cable and harness.[9][10][11] The third category of available prosthetic devices comprises myoelectric arms. This particular class of devices distinguishes itself from the previous ones due to the inclusion of a battery system. This battery serves the dual purpose of providing energy for both actuation and sensing components. While actuation predominantly relies on motor or pneumatic systems,[12] a variety of solutions have been explored for capturing muscle activity, including techniques such as Electromyography, Sonomyography, Myokinetic, and others.[13][14][15] These methods function by detecting the minute electrical currents generated by contracted muscles during upper arm movement, typically employing electrodes or other suitable tools. Subsequently, these acquired signals are converted into gripping patterns or postures that the artificial hand will then execute.

In the prosthetics industry, a trans-radial prosthetic arm is often referred to as a "BE" or below elbow prosthesis.

Lower-extremity prostheses provide replacements at varying levels of amputation. These include hip disarticulation, transfemoral prosthesis, knee disarticulation, transtibial prosthesis, Syme's amputation, foot, partial foot, and toe. The two main subcategories of lower extremity prosthetic devices are trans-tibial (any amputation transecting the tibia bone or a congenital anomaly resulting in a tibial deficiency) and trans-femoral (any amputation transecting the femur bone or a congenital anomaly resulting in a femoral deficiency).[citation needed]

A transfemoral prosthesis is an artificial limb that replaces a leg missing above the knee. Transfemoral amputees can have a very difficult time regaining normal movement. In general, a transfemoral amputee must use approximately 80% more energy to walk than a person with two whole legs.[16] This is due to the complexities in movement associated with the knee. In newer and more improved designs, hydraulics, carbon fiber, mechanical linkages, motors, computer microprocessors, and innovative combinations of these technologies are employed to give more control to the user. In the prosthetics industry, a trans-femoral prosthetic leg is often referred to as an "AK" or above the knee prosthesis.

A transtibial prosthesis is an artificial limb that replaces a leg missing below the knee. A transtibial amputee is usually able to regain normal movement more readily than someone with a transfemoral amputation, due in large part to retaining the knee, which allows for easier movement. Lower extremity prosthetics describe artificially replaced limbs located at the hip level or lower. In the prosthetics industry, a trans-tibial prosthetic leg is often referred to as a "BK" or below the knee prosthesis.

Prostheses are manufactured and fit by clinical prosthetists. Prosthetists are healthcare professionals responsible for making, fitting, and adjusting prostheses and for lower limb prostheses will assess both gait and prosthetic alignment. Once a prosthesis has been fit and adjusted by a prosthetist, a rehabilitation physiotherapist (called physical therapist in America) will help teach a new prosthetic user to walk with a leg prosthesis. To do so, the physical therapist may provide verbal instructions and may also help guide the person using touch or tactile cues. This may be done in a clinic or home. There is some research suggesting that such training in the home may be more successful if the treatment includes the use of a treadmill.[17] Using a treadmill, along with the physical therapy treatment, helps the person to experience many of the challenges of walking with a prosthesis.

In the United Kingdom, 75% of lower limb amputations are performed due to inadequate circulation (dysvascularity).[18] This condition is often associated with many other medical conditions (co-morbidities) including diabetes and heart disease that may make it a challenge to recover and use a prosthetic limb to regain mobility and independence.[18] For people who have inadequate circulation and have lost a lower limb, there is insufficient evidence due to a lack of research, to inform them regarding their choice of prosthetic rehabilitation approaches.[18]

Types of prosthesis used for replacing joints in the human body

Lower extremity prostheses are often categorized by the level of amputation or after the name of a surgeon:[19][20]

  • Transfemoral (Above-knee)
  • Transtibial (Below-knee)
  • Ankle disarticulation (more commonly known as Syme's amputation)
  • Knee disarticulation (also see knee replacement)
  • Hip disarticulation, (also see hip replacement)
  • Hemi-pelvictomy
  • Partial foot amputations (Pirogoff, Talo-Navicular and Calcaneo-cuboid (Chopart), Tarso-metatarsal (Lisfranc), Trans-metatarsal, Metatarsal-phalangeal, Ray amputations, toe amputations).[20]
  • Van Nes rotationplasty

Prosthetic raw materials

[edit]

Prosthetic are made lightweight for better convenience for the amputee. Some of these materials include:

  • Plastics:
    • Polyethylene
    • Polypropylene
    • Acrylics
    • Polyurethane
  • Wood (early prosthetics)
  • Rubber (early prosthetics)
  • Lightweight metals:
    • Aluminum
  • Composites:
    • Carbon fiber reinforced polymers[4]

Wheeled prostheses have also been used extensively in the rehabilitation of injured domestic animals, including dogs, cats, pigs, rabbits, and turtles.[21]

Organ prostheses

[edit]

Organ prostheses include artificial hearts, and artificial kidneys.

History

[edit]
Prosthetic toe from ancient Egypt, dated between 950-710 BCE.[22]

Prosthetics originate from the ancient Near East circa 3000 BCE, with the earliest evidence of prosthetics appearing in ancient Egypt and Iran. The earliest recorded mention of eye prosthetics is from the Egyptian story of the Eye of Horus dated circa 3000 BC, which involves the left eye of Horus being plucked out and then restored by Thoth. Circa 3000-2800 BC, the earliest archaeological evidence of prosthetics is found in ancient Iran, where an eye prosthetic is found buried with a woman in Shahr-i Shōkhta. It was likely made of bitumen paste that was covered with a thin layer of gold.[23] The Egyptians were also early pioneers of foot prosthetics, as shown by the wooden toe found on a body from the New Kingdom circa 1000 BC.[24] Another early textual mention is found in South Asia circa 1200 BC, involving the warrior queen Vishpala in the Rigveda.[25] Roman bronze crowns have also been found, but their use could have been more aesthetic than medical.[26]

An early mention of a prosthetic comes from the Greek historian Herodotus, who tells the story of Hegesistratus, a Greek diviner who cut off his own foot to escape his Spartan captors and replaced it with a wooden one.[27]

Wood and metal prosthetics

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The Capua leg (replica)
A wooden prosthetic leg from Shengjindian cemetery, circa 300 BCE, Turpan Museum. This is "the oldest functional leg prosthesis known to date".[28]
Iron prosthetic hand believed to have been owned by Götz von Berlichingen (1480–1562)
"Illustration of mechanical hand", c. 1564
Artificial iron hand believed to date from 1560 to 1600

Pliny the Elder also recorded the tale of a Roman general, Marcus Sergius, whose right hand was cut off while campaigning and had an iron hand made to hold his shield so that he could return to battle. A famous and quite refined[29] historical prosthetic arm was that of Götz von Berlichingen, made at the beginning of the 16th century. The first confirmed use of a prosthetic device, however, is from 950 to 710 BC. In 2000, research pathologists discovered a mummy from this period buried in the Egyptian necropolis near ancient Thebes that possessed an artificial big toe. This toe, consisting of wood and leather, exhibited evidence of use. When reproduced by bio-mechanical engineers in 2011, researchers discovered that this ancient prosthetic enabled its wearer to walk both barefoot and in Egyptian style sandals. Previously, the earliest discovered prosthetic was an artificial leg from Capua.[30]

Around the same time, François de la Noue is also reported to have had an iron hand, as is, in the 17th century, René-Robert Cavalier de la Salle.[31] Henri de Tonti had a prosthetic hook for a hand. During the Middle Ages, prosthetics remained quite basic in form. Debilitated knights would be fitted with prosthetics so they could hold up a shield, grasp a lance or a sword, or stabilize a mounted warrior.[32] Only the wealthy could afford anything that would assist in daily life.[33]

One notable prosthesis was that belonging to an Italian man, who scientists estimate replaced his amputated right hand with a knife.[34][35] Scientists investigating the skeleton, which was found in a Longobard cemetery in Povegliano Veronese, estimated that the man had lived sometime between the 6th and 8th centuries AD.[36][35] Materials found near the man's body suggest that the knife prosthesis was attached with a leather strap, which he repeatedly tightened with his teeth.[36]

During the Renaissance, prosthetics developed with the use of iron, steel, copper, and wood. Functional prosthetics began to make an appearance in the 1500s.[37]

Technology progress before the 20th century

[edit]

An Italian surgeon recorded the existence of an amputee who had an arm that allowed him to remove his hat, open his purse, and sign his name.[38] Improvement in amputation surgery and prosthetic design came at the hands of Ambroise Paré. Among his inventions was an above-knee device that was a kneeling peg leg and foot prosthesis with a fixed position, adjustable harness, and knee lock control. The functionality of his advancements showed how future prosthetics could develop.

Other major improvements before the modern era:

  • Pieter Verduyn – First non-locking below-knee (BK) prosthesis.
  • James Potts – Prosthesis made of a wooden shank and socket, a steel knee joint and an articulated foot that was controlled by catgut tendons from the knee to the ankle. Came to be known as "Anglesey Leg" or "Selpho Leg".
  • Sir James Syme – A new method of ankle amputation that did not involve amputating at the thigh.
  • Benjamin Palmer – Improved upon the Selpho leg. Added an anterior spring and concealed tendons to simulate natural-looking movement.
  • Dubois Parmlee – Created prosthetic with a suction socket, polycentric knee, and multi-articulated foot.
  • Marcel Desoutter and Charles Desoutter – First aluminium prosthesis[39]
  • Henry Heather Bigg, and his son Henry Robert Heather Bigg, won the Queen's command to provide "surgical appliances" to wounded soldiers after Crimea War. They developed arms that allowed a double arm amputee to crochet, and a hand that felt natural to others based on ivory, felt and leather.[40]

At the end of World War II, the NAS (National Academy of Sciences) began to advocate better research and development of prosthetics. Through government funding, a research and development program was developed within the Army, Navy, Air Force, and the Veterans Administration.

Lower extremity modern history

[edit]
An artificial limbs factory in 1941

After the Second World War, a team at the University of California, Berkeley including James Foort and C.W. Radcliff helped to develop the quadrilateral socket by developing a jig fitting system for amputations above the knee. Socket technology for lower extremity limbs saw a further revolution during the 1980s when John Sabolich C.P.O., invented the Contoured Adducted Trochanteric-Controlled Alignment Method (CATCAM) socket, later to evolve into the Sabolich Socket. He followed the direction of Ivan Long and Ossur Christensen as they developed alternatives to the quadrilateral socket, which in turn followed the open ended plug socket, created from wood.[41] The advancement was due to the difference in the socket to patient contact model. Prior to this, sockets were made in the shape of a square shape with no specialized containment for muscular tissue. New designs thus help to lock in the bony anatomy, locking it into place and distributing the weight evenly over the existing limb as well as the musculature of the patient. Ischial containment is well known and used today by many prosthetist to help in patient care. Variations of the ischial containment socket thus exists and each socket is tailored to the specific needs of the patient. Others who contributed to socket development and changes over the years include Tim Staats, Chris Hoyt, and Frank Gottschalk. Gottschalk disputed the efficacy of the CAT-CAM socket- insisting the surgical procedure done by the amputation surgeon was most important to prepare the amputee for good use of a prosthesis of any type socket design.[42]

The first microprocessor-controlled prosthetic knees became available in the early 1990s. The Intelligent Prosthesis was the first commercially available microprocessor-controlled prosthetic knee. It was released by Chas. A. Blatchford & Sons, Ltd., of Great Britain, in 1993 and made walking with the prosthesis feel and look more natural.[43] An improved version was released in 1995 by the name Intelligent Prosthesis Plus. Blatchford released another prosthesis, the Adaptive Prosthesis, in 1998. The Adaptive Prosthesis utilized hydraulic controls, pneumatic controls, and a microprocessor to provide the amputee with a gait that was more responsive to changes in walking speed. Cost analysis reveals that a sophisticated above-knee prosthesis will be about $1 million in 45 years, given only annual cost of living adjustments.[44]

In 2019, a project under AT2030 was launched in which bespoke sockets are made using a thermoplastic, rather than through a plaster cast. This is faster to do and significantly less expensive. The sockets were called Amparo Confidence sockets.[45][46]

Upper extremity modern history

[edit]
DARPA Revolutionizing Prosthetics - The LUKE Arm

In 2005, DARPA started the Revolutionizing Prosthetics program.[47][48][49][50][51][52] According to DARPA, the goal of the $100 million program was to "develop an advanced electromechanical prosthetic upper limb with near-natural control that would dramatically enhance independence and quality of life for amputees."[53][54] In 2014, the LUKE Arm developed by Dean Kamen and his team at DEKA Research and Development Corp. became the first prosthetic arm approved by FDA that "translates signals from a person's muscles to perform complex tasks," according to FDA.[54][55] Johns Hopkins University and the U.S. Department of Veteran Affairs also participated in the program.[54][56]

[edit]

There are many steps in the evolution of prosthetic design trends that are moving forward with time. Many design trends point to lighter, more durable, and flexible materials like carbon fiber, silicone, and advanced polymers. These not only make the prosthetic limb lighter and more durable but also allow it to mimic the look and feel of natural skin, providing users with a more comfortable and natural experience.[57] This new technology helps prosthetic users blend in with people with normal ligaments to reduce the stigmatism for people who wear prosthetics. Another trend points towards using bionics and myoelectric components in prosthetic design. These limbs utilize sensors to detect electrical signals from the user's residual muscles. The signals are then converted into motions, allowing users to control their prosthetic limbs using their own muscle contractions. This has greatly improved the range and fluidity of movements available to amputees, making tasks like grasping objects or walking naturally much more feasible.[57] Integration with AI is also on the forefront to the prosthetic design. AI-enabled prosthetic limbs can learn and adapt to the user's habits and preferences over time, ensuring optimal functionality. By analyzing the user's gait, grip, and other movements, these smart limbs can make real-time adjustments, providing smoother and more natural motions.[57]

Patient procedure

[edit]

A prosthesis is a functional replacement for an amputated or congenitally malformed or missing limb. Prosthetists are responsible for the prescription, design, and management of a prosthetic device.

In most cases, the prosthetist begins by taking a plaster cast of the patient's affected limb. Lightweight, high-strength thermoplastics are custom-formed to this model of the patient. Cutting-edge materials such as carbon fiber, titanium and Kevlar provide strength and durability while making the new prosthesis lighter. More sophisticated prostheses are equipped with advanced electronics, providing additional stability and control.[58]

Current technology and manufacturing

[edit]
Knee prosthesis manufactured using WorkNC Computer Aided Manufacturing software

Over the years, there have been advancements in artificial limbs. New plastics and other materials, such as carbon fiber, have allowed artificial limbs to be stronger and lighter, limiting the amount of extra energy necessary to operate the limb. This is especially important for trans-femoral amputees. Additional materials have allowed artificial limbs to look much more realistic, which is important to trans-radial and transhumeral amputees because they are more likely to have the artificial limb exposed.[59]

Manufacturing a prosthetic finger

In addition to new materials, the use of electronics has become very common in artificial limbs. Myoelectric limbs, which control the limbs by converting muscle movements to electrical signals, have become much more common than cable operated limbs. Myoelectric signals are picked up by electrodes, the signal gets integrated and once it exceeds a certain threshold, the prosthetic limb control signal is triggered which is why inherently, all myoelectric controls lag. Conversely, cable control is immediate and physical, and through that offers a certain degree of direct force feedback that myoelectric control does not. Computers are also used extensively in the manufacturing of limbs. Computer Aided Design and Computer Aided Manufacturing are often used to assist in the design and manufacture of artificial limbs.[59][60]

Most modern artificial limbs are attached to the residual limb (stump) of the amputee by belts and cuffs or by suction. The residual limb either directly fits into a socket on the prosthetic, or—more commonly today—a liner is used that then is fixed to the socket either by vacuum (suction sockets) or a pin lock. Liners are soft and by that, they can create a far better suction fit than hard sockets. Silicone liners can be obtained in standard sizes, mostly with a circular (round) cross section, but for any other residual limb shape, custom liners can be made. The socket is custom made to fit the residual limb and to distribute the forces of the artificial limb across the area of the residual limb (rather than just one small spot), which helps reduce wear on the residual limb.

Production of prosthetic socket

[edit]

The production of a prosthetic socket begins with capturing the geometry of the residual limb; this process is called shape capture. The goal of this process is to create an accurate representation of the residual limb, which is critical to achieve good socket fit.[61] The custom socket is created by taking a plaster cast of the residual limb or, more commonly today, of the liner worn over their residual limb, and then making a mold from the plaster cast. The commonly used compound is called Plaster of Paris.[62] In recent years, various digital shape capture systems have been developed which can be input directly to a computer allowing for a more sophisticated design. In general, the shape capturing process begins with the digital acquisition of three-dimensional (3D) geometric data from the amputee's residual limb. Data are acquired with either a probe, laser scanner, structured light scanner, or a photographic-based 3D scanning system.[63]

After shape capture, the second phase of the socket production is called rectification, which is the process of modifying the model of the residual limb by adding volume to bony prominence and potential pressure points and remove volume from load bearing area. This can be done manually by adding or removing plaster to the positive model, or virtually by manipulating the computerized model in the software.[64] Lastly, the fabrication of the prosthetic socket begins once the model has been rectified and finalized. The prosthetists would wrap the positive model with a semi-molten plastic sheet or carbon fiber coated with epoxy resin to construct the prosthetic socket.[61] For the computerized model, it can be 3D printed using a various of material with different flexibility and mechanical strength.[65]

Optimal socket fit between the residual limb and socket is critical to the function and usage of the entire prosthesis. If the fit between the residual limb and socket attachment is too loose, this will reduce the area of contact between the residual limb and socket or liner, and increase pockets between residual limb skin and socket or liner. Pressure then is higher, which can be painful. Air pockets can allow sweat to accumulate that can soften the skin. Ultimately, this is a frequent cause for itchy skin rashes. Over time, this can lead to breakdown of the skin.[16] On the other hand, a very tight fit may excessively increase the interface pressures that may also lead to skin breakdown after prolonged use.[66]

Artificial limbs are typically manufactured using the following steps:[59]

  1. Measurement of the residual limb
  2. Measurement of the body to determine the size required for the artificial limb
  3. Fitting of a silicone liner
  4. Creation of a model of the liner worn over the residual limb
  5. Formation of thermoplastic sheet around the model – This is then used to test the fit of the prosthetic
  6. Formation of permanent socket
  7. Formation of plastic parts of the artificial limb – Different methods are used, including vacuum forming and injection molding
  8. Creation of metal parts of the artificial limb using die casting
  9. Assembly of entire limb

Body-powered arms

[edit]

Current technology allows body-powered arms to weigh around one-half to one-third of what a myoelectric arm does.

Sockets

[edit]

Current body-powered arms contain sockets that are built from hard epoxy or carbon fiber. These sockets or "interfaces" can be made more comfortable by lining them with a softer, compressible foam material that provides padding for the bone prominences. A self-suspending or supra-condylar socket design is useful for those with short to mid-range below elbow absence. Longer limbs may require the use of a locking roll-on type inner liner or more complex harnessing to help augment suspension.

Wrists

[edit]

Wrist units are either screw-on connectors featuring the UNF 1/2-20 thread (USA) or quick-release connector, of which there are different models.

Voluntary opening and voluntary closing

[edit]

Two types of body-powered systems exist, voluntary opening "pull to open" and voluntary closing "pull to close". Virtually all "split hook" prostheses operate with a voluntary opening type system.

More modern "prehensors" called GRIPS utilize voluntary closing systems. The differences are significant. Users of voluntary opening systems rely on elastic bands or springs for gripping force, while users of voluntary closing systems rely on their own body power and energy to create gripping force.

Voluntary closing users can generate prehension forces equivalent to the normal hand, up to or exceeding one hundred pounds. Voluntary closing GRIPS require constant tension to grip, like a human hand, and in that property, they do come closer to matching human hand performance. Voluntary opening split hook users are limited to forces their rubber or springs can generate which usually is below 20 pounds.

Feedback

[edit]

An additional difference exists in the biofeedback created that allows the user to "feel" what is being held. Voluntary opening systems once engaged provide the holding force so that they operate like a passive vice at the end of the arm. No gripping feedback is provided once the hook has closed around the object being held. Voluntary closing systems provide directly proportional control and biofeedback so that the user can feel how much force that they are applying.

In 1997, the Colombian Prof. Álvaro Ríos Poveda, a researcher in bionics in Latin America, developed an upper limb and hand prosthesis with sensory feedback. This technology allows amputee patients to handle prosthetic hand systems in a more natural way.[67]

A recent study showed that by stimulating the median and ulnar nerves, according to the information provided by the artificial sensors from a hand prosthesis, physiologically appropriate (near-natural) sensory information could be provided to an amputee. This feedback enabled the participant to effectively modulate the grasping force of the prosthesis with no visual or auditory feedback.[68]

In February 2013, researchers from École Polytechnique Fédérale de Lausanne in Switzerland and the Scuola Superiore Sant'Anna in Italy, implanted electrodes into an amputee's arm, which gave the patient sensory feedback and allowed for real time control of the prosthetic.[69] With wires linked to nerves in his upper arm, the Danish patient was able to handle objects and instantly receive a sense of touch through the special artificial hand that was created by Silvestro Micera and researchers both in Switzerland and Italy.[70]

In July 2019, this technology was expanded on even further by researchers from the University of Utah, led by Jacob George. The group of researchers implanted electrodes into the patient's arm to map out several sensory precepts. They would then stimulate each electrode to figure out how each sensory precept was triggered, then proceed to map the sensory information onto the prosthetic. This would allow the researchers to get a good approximation of the same kind of information that the patient would receive from their natural hand. Unfortunately, the arm is too expensive for the average user to acquire, however, Jacob mentioned that insurance companies could cover the costs of the prosthetic.[71]

Terminal devices

[edit]

Terminal devices contain a range of hooks, prehensors, hands or other devices.

Hooks
[edit]

Voluntary opening split hook systems are simple, convenient, light, robust, versatile and relatively affordable.

A hook does not match a normal human hand for appearance or overall versatility, but its material tolerances can exceed and surpass the normal human hand for mechanical stress (one can even use a hook to slice open boxes or as a hammer whereas the same is not possible with a normal hand), for thermal stability (one can use a hook to grip items from boiling water, to turn meat on a grill, to hold a match until it has burned down completely) and for chemical hazards (as a metal hook withstands acids or lye, and does not react to solvents like a prosthetic glove or human skin).

Hands
[edit]
Actor Owen Wilson gripping the myoelectric prosthetic arm of a United States Marine

Prosthetic hands are available in both voluntary opening and voluntary closing versions and because of their more complex mechanics and cosmetic glove covering require a relatively large activation force, which, depending on the type of harness used, may be uncomfortable.[72] A recent study by the Delft University of Technology, The Netherlands, showed that the development of mechanical prosthetic hands has been neglected during the past decades. The study showed that the pinch force level of most current mechanical hands is too low for practical use.[73] The best tested hand was a prosthetic hand developed around 1945. In 2017 however, a research has been started with bionic hands by Laura Hruby of the Medical University of Vienna.[74][75] A few open-hardware 3-D printable bionic hands have also become available.[76] Some companies are also producing robotic hands with integrated forearm, for fitting unto a patient's upper arm[77][78] and in 2020, at the Italian Institute of Technology (IIT), another robotic hand with integrated forearm (Soft Hand Pro) was developed.[79]

Commercial providers and materials

[edit]

Hosmer and Otto Bock are major commercial hook providers. Mechanical hands are sold by Hosmer and Otto Bock as well; the Becker Hand is still manufactured by the Becker family. Prosthetic hands may be fitted with standard stock or custom-made cosmetic looking silicone gloves. But regular work gloves may be worn as well. Other terminal devices include the V2P Prehensor, a versatile robust gripper that allows customers to modify aspects of it, Texas Assist Devices (with a whole assortment of tools) and TRS that offers a range of terminal devices for sports. Cable harnesses can be built using aircraft steel cables, ball hinges, and self-lubricating cable sheaths. Some prosthetics have been designed specifically for use in salt water.[80]

Lower-extremity prosthetics

[edit]
A prosthetic leg worn by Ellie Cole

Lower-extremity prosthetics describes artificially replaced limbs located at the hip level or lower. Concerning all ages Ephraim et al. (2003) found a worldwide estimate of all-cause lower-extremity amputations of 2.0–5.9 per 10,000 inhabitants. For birth prevalence rates of congenital limb deficiency they found an estimate between 3.5 and 7.1 cases per 10,000 births.[81]

The two main subcategories of lower extremity prosthetic devices are trans-tibial (any amputation transecting the tibia bone or a congenital anomaly resulting in a tibial deficiency), and trans-femoral (any amputation transecting the femur bone or a congenital anomaly resulting in a femoral deficiency). In the prosthetic industry, a trans-tibial prosthetic leg is often referred to as a "BK" or below the knee prosthesis while the trans-femoral prosthetic leg is often referred to as an "AK" or above the knee prosthesis.

Other, less prevalent lower extremity cases include the following:

  1. Hip disarticulations – This usually refers to when an amputee or congenitally challenged patient has either an amputation or anomaly at or in close proximity to the hip joint. See hip replacement
  2. Knee disarticulations – This usually refers to an amputation through the knee disarticulating the femur from the tibia. See knee replacement
  3. Symes – This is an ankle disarticulation while preserving the heel pad.

Socket

[edit]

The socket serves as an interface between the residuum and the prosthesis, ideally allowing comfortable weight-bearing, movement control and proprioception.[82] Socket problems, such as discomfort and skin breakdown, are rated among the most important issues faced by lower-limb amputees.[83]

Shank and connectors

[edit]

This part creates distance and support between the knee-joint and the foot (in case of an upper-leg prosthesis) or between the socket and the foot. The type of connectors that are used between the shank and the knee/foot determines whether the prosthesis is modular or not. Modular means that the angle and the displacement of the foot in respect to the socket can be changed after fitting. In developing countries prosthesis mostly are non-modular, in order to reduce cost. When considering children modularity of angle and height is important because of their average growth of 1.9 cm annually.[84]

[edit]

Providing contact to the ground, the foot provides shock absorption and stability during stance.[85] Additionally it influences gait biomechanics by its shape and stiffness. This is because the trajectory of the center of pressure (COP) and the angle of the ground reaction forces is determined by the shape and stiffness of the foot and needs to match the subject's build in order to produce a normal gait pattern.[86] Andrysek (2010) found 16 different types of feet, with greatly varying results concerning durability and biomechanics. The main problem found in current feet is durability, endurance ranging from 16 to 32 months[87] These results are for adults and will probably be worse for children due to higher activity levels and scale effects. Evidence comparing different types of feet and ankle prosthetic devices is not strong enough to determine if one mechanism of ankle/foot is superior to another.[88] When deciding on a device, the cost of the device, a person's functional need, and the availability of a particular device should be considered.[88]

Knee joint

[edit]

In case of a trans-femoral (above knee) amputation, there also is a need for a complex connector providing articulation, allowing flexion during swing-phase but not during stance. As its purpose is to replace the knee, the prosthetic knee joint is the most critical component of the prosthesis for trans-femoral amputees. The function of the good prosthetic knee joint is to mimic the function of the normal knee, such as providing structural support and stability during stance phase but able to flex in a controllable manner during swing phase. Hence it allows users to have a smooth and energy efficient gait and minimize the impact of amputation.[89] The prosthetic knee is connected to the prosthetic foot by the shank, which is usually made of an aluminum or graphite tube.

One of the most important aspect of a prosthetic knee joint would be its stance-phase control mechanism. The function of stance-phase control is to prevent the leg from buckling when the limb is loaded during weight acceptance. This ensures the stability of the knee in order to support the single limb support task of stance phase and provides a smooth transition to the swing phase. Stance phase control can be achieved in several ways including the mechanical locks,[90] relative alignment of prosthetic components,[91] weight activated friction control,[91] and polycentric mechanisms.[92]

Microprocessor control
[edit]

To mimic the knee's functionality during gait, microprocessor-controlled knee joints have been developed that control the flexion of the knee. Some examples are Otto Bock's C-leg, introduced in 1997, Ossur's Rheo Knee, released in 2005, the Power Knee by Ossur, introduced in 2006, the Plié Knee from Freedom Innovations and DAW Industries' Self Learning Knee (SLK).[93]

The idea was originally developed by Kelly James, a Canadian engineer, at the University of Alberta.[94]

A microprocessor is used to interpret and analyze signals from knee-angle sensors and moment sensors. The microprocessor receives signals from its sensors to determine the type of motion being employed by the amputee. Most microprocessor controlled knee-joints are powered by a battery housed inside the prosthesis.

The sensory signals computed by the microprocessor are used to control the resistance generated by hydraulic cylinders in the knee-joint. Small valves control the amount of hydraulic fluid that can pass into and out of the cylinder, thus regulating the extension and compression of a piston connected to the upper section of the knee.[44]

The main advantage of a microprocessor-controlled prosthesis is a closer approximation to an amputee's natural gait. Some allow amputees to walk near walking speed or run. Variations in speed are also possible and are taken into account by sensors and communicated to the microprocessor, which adjusts to these changes accordingly. It also enables the amputees to walk downstairs with a step-over-step approach, rather than the one step at a time approach used with mechanical knees.[95] There is some research suggesting that people with microprocessor-controlled prostheses report greater satisfaction and improvement in functionality, residual limb health, and safety.[96] People may be able to perform everyday activities at greater speeds, even while multitasking, and reduce their risk of falls.[96]

However, some have some significant drawbacks that impair its use. They can be susceptible to water damage and thus great care must be taken to ensure that the prosthesis remains dry.[97]

Myoelectric

[edit]

A myoelectric prosthesis uses the electrical tension generated every time a muscle contracts, as information. This tension can be captured from voluntarily contracted muscles by electrodes applied on the skin to control the movements of the prosthesis, such as elbow flexion/extension, wrist supination/pronation (rotation) or opening/closing of the fingers. A prosthesis of this type utilizes the residual neuromuscular system of the human body to control the functions of an electric powered prosthetic hand, wrist, elbow or foot.[98] This is different from an electric switch prosthesis, which requires straps and/or cables actuated by body movements to actuate or operate switches that control the movements of the prosthesis. There is no clear evidence concluding that myoelectric upper extremity prostheses function better than body-powered prostheses.[99] Advantages to using a myoelectric upper extremity prosthesis include the potential for improvement in cosmetic appeal (this type of prosthesis may have a more natural look), may be better for light everyday activities, and may be beneficial for people experiencing phantom limb pain.[99] When compared to a body-powered prosthesis, a myoelectric prosthesis may not be as durable, may have a longer training time, may require more adjustments, may need more maintenance, and does not provide feedback to the user.[99]

Prof. Alvaro Ríos Poveda has been working for several years on a non-invasive and affordable solution to this feedback problem. He considers that: "Prosthetic limbs that can be controlled with thought hold great promise for the amputee, but without sensorial feedback from the signals returning to the brain, it can be difficult to achieve the level of control necessary to perform precise movements. When connecting the sense of touch from a mechanical hand directly to the brain, prosthetics can restore the function of the amputated limb in an almost natural-feeling way." He presented the first Myoelectric prosthetic hand with sensory feedback at the XVIII World Congress on Medical Physics and Biomedical Engineering, 1997, held in Nice, France.[100][101]

The USSR was the first to develop a myoelectric arm in 1958,[102] while the first myoelectric arm became commercial in 1964 by the Central Prosthetic Research Institute of the USSR, and distributed by the Hangar Limb Factory of the UK.[103][104] Myoelectric prosthesis are expensive, require regular maintenance, and are sensitive to sweat and moisture.

Robotic prostheses

[edit]
Brain control of 3D prosthetic arm movement (hitting targets). This movie was recorded when the participant controlled the 3D movement of a prosthetic arm to hit physical targets in a research lab.

Robots can be used to generate objective measures of patient's impairment and therapy outcome, assist in diagnosis, customize therapies based on patient's motor abilities, and assure compliance with treatment regimens and maintain patient's records. It is shown in many studies that there is a significant improvement in upper limb motor function after stroke using robotics for upper limb rehabilitation.[105] In order for a robotic prosthetic limb to work, it must have several components to integrate it into the body's function: Biosensors detect signals from the user's nervous or muscular systems. It then relays this information to a microcontroller located inside the device, and processes feedback from the limb and actuator, e.g., position or force, and sends it to the controller. Examples include surface electrodes that detect electrical activity on the skin, needle electrodes implanted in muscle, or solid-state electrode arrays with nerves growing through them. One type of these biosensors are employed in myoelectric prostheses.

A device known as the controller is connected to the user's nerve and muscular systems and the device itself. It sends intention commands from the user to the actuators of the device and interprets feedback from the mechanical and biosensors to the user. The controller is also responsible for the monitoring and control of the movements of the device.

An actuator mimics the actions of a muscle in producing force and movement. Examples include a motor that aids or replaces original muscle tissue.

Targeted muscle reinnervation (TMR) is a technique in which motor nerves, which previously controlled muscles on an amputated limb, are surgically rerouted such that they reinnervate a small region of a large, intact muscle, such as the pectoralis major. As a result, when a patient thinks about moving the thumb of their missing hand, a small area of muscle on their chest will contract instead. By placing sensors over the reinnervated muscle, these contractions can be made to control the movement of an appropriate part of the robotic prosthesis.[106][107]

A variant of this technique is called targeted sensory reinnervation (TSR). This procedure is similar to TMR, except that sensory nerves are surgically rerouted to skin on the chest, rather than motor nerves rerouted to muscle. Recently, robotic limbs have improved in their ability to take signals from the human brain and translate those signals into motion in the artificial limb. DARPA, the Pentagon's research division, is working to make even more advancements in this area. Their desire is to create an artificial limb that ties directly into the nervous system.[108]

Robotic arms

[edit]

Advancements in the processors used in myoelectric arms have allowed developers to make gains in fine-tuned control of the prosthetic. The Boston Digital Arm is a recent artificial limb that has taken advantage of these more advanced processors. The arm allows movement in five axes and allows the arm to be programmed for a more customized feel. Recently the I-LIMB Hand, invented in Edinburgh, Scotland, by David Gow has become the first commercially available hand prosthesis with five individually powered digits. The hand also possesses a manually rotatable thumb which is operated passively by the user and allows the hand to grip in precision, power, and key grip modes.[109]

Another neural prosthetic is Johns Hopkins University Applied Physics Laboratory Proto 1. Besides the Proto 1, the university also finished the Proto 2 in 2010.[110] Early in 2013, Max Ortiz Catalan and Rickard Brånemark of the Chalmers University of Technology, and Sahlgrenska University Hospital in Sweden, succeeded in making the first robotic arm which is mind-controlled and can be permanently attached to the body (using osseointegration).[111][112][113]

An approach that is very useful is called arm rotation which is common for unilateral amputees which is an amputation that affects only one side of the body; and also essential for bilateral amputees, a person who is missing or has had amputated either both arms or legs, to carry out activities of daily living. This involves inserting a small permanent magnet into the distal end of the residual bone of subjects with upper limb amputations. When a subject rotates the residual arm, the magnet will rotate with the residual bone, causing a change in magnetic field distribution.[114] EEG (electroencephalogram) signals, detected using small flat metal discs attached to the scalp, essentially decoding human brain activity used for physical movement, is used to control the robotic limbs. This allows the user to control the part directly.[115]

Robotic transtibial prostheses

[edit]

The research of robotic legs has made some advancement over time, allowing exact movement and control.

Researchers at the Rehabilitation Institute of Chicago announced in September 2013 that they have developed a robotic leg that translates neural impulses from the user's thigh muscles into movement, which is the first prosthetic leg to do so. It is currently in testing.[116]

Hugh Herr, head of the biomechatronics group at MIT's Media Lab developed a robotic transtibial leg (PowerFoot BiOM).[117][118]

The Icelandic company Össur has also created a robotic transtibial leg with motorized ankle that moves through algorithms and sensors that automatically adjust the angle of the foot during different points in its wearer's stride. Also there are brain-controlled bionic legs that allow an individual to move his limbs with a wireless transmitter.[119]

Prosthesis design

[edit]

The main goal of a robotic prosthesis is to provide active actuation during gait to improve the biomechanics of gait, including, among other things, stability, symmetry, or energy expenditure for amputees.[120] There are several powered prosthetic legs currently on the market, including fully powered legs, in which actuators directly drive the joints, and semi-active legs, which use small amounts of energy and a small actuator to change the mechanical properties of the leg but do not inject net positive energy into gait. Specific examples include The emPOWER from BionX, the Proprio Foot from Ossur, and the Elan Foot from Endolite.[121][122][123] Various research groups have also experimented with robotic legs over the last decade.[124] Central issues being researched include designing the behavior of the device during stance and swing phases, recognizing the current ambulation task, and various mechanical design problems such as robustness, weight, battery-life/efficiency, and noise-level. However, scientists from Stanford University and Seoul National University has developed artificial nerves system that will help prosthetic limbs feel.[125] This synthetic nerve system enables prosthetic limbs sense braille, feel the sense of touch and respond to the environment.[126][127]

Use of recycled materials

[edit]

Prosthetics are being made from recycled plastic bottles and lids around the world.[128][129][130][131][132]

Direct bone attachment and osseointegration

[edit]

Most prostheses are attached to the exterior of the body in a non-permanent way. The stump and socket method can cause significant pain for the person, which is why direct bone attachment has been explored extensively.

Osseointegration is a method of attaching the artificial limb to the body by a prosthetic implant. This method is also sometimes referred to as exoprosthesis (attaching an artificial limb to the bone), or endo-exoprosthesis. Endoprosthesis are prosthetic joint implants which remain wholly inside the body such as knee and hip replacement implants.

The method works by inserting a titanium bolt into the bone at the end of the stump. After several months the bone attaches itself to the titanium bolt and an abutment is attached to the titanium bolt. The abutment extends out of the stump and the (removable) artificial limb is then attached to the abutment. Some of the benefits of this method include the following:

  • Better muscle control of the prosthetic.
  • The ability to wear the prosthetic for an extended period of time; with the stump and socket method this is not possible.
  • The ability for transfemoral amputees to drive a car.

The main disadvantage of this method is that amputees with the direct bone attachment cannot have large impacts on the limb, such as those experienced during jogging, because of the potential for the bone to break.[16]

Cosmesis

[edit]

Cosmetic prosthesis has long been used to disguise injuries and disfigurements. With advances in modern technology, cosmesis, the creation of lifelike limbs made from silicone or PVC, has been made possible.[133] Such prosthetics, including artificial hands, can now be designed to simulate the appearance of real hands, complete with freckles, veins, hair, fingerprints and even tattoos. Custom-made cosmeses are generally more expensive (costing thousands of U.S. dollars, depending on the level of detail), while standard cosmeses come premade in a variety of sizes, although they are often not as realistic as their custom-made counterparts. Another option is the custom-made silicone cover, which can be made to match a person's skin tone but not details such as freckles or wrinkles. Cosmeses are attached to the body in any number of ways, using an adhesive, suction, form-fitting, stretchable skin, or a skin sleeve.

Cognition

[edit]

Unlike neuromotor prostheses, neurocognitive prostheses would sense or modulate neural function in order to physically reconstitute or augment cognitive processes such as executive function, attention, language, and memory. No neurocognitive prostheses are currently available but the development of implantable neurocognitive brain-computer interfaces has been proposed to help treat conditions such as stroke, traumatic brain injury, cerebral palsy, autism, and Alzheimer's disease.[134] The recent field of Assistive Technology for Cognition concerns the development of technologies to augment human cognition. Scheduling devices such as Neuropage remind users with memory impairments when to perform certain activities, such as visiting the doctor. Micro-prompting devices such as PEAT, AbleLink and Guide have been used to aid users with memory and executive function problems perform activities of daily living.

Prosthetic enhancement

[edit]
Sgt. Jerrod Fields works out at the U.S. Olympic Training Center in Chula Vista, California.

In addition to the standard artificial limb for everyday use, many amputees or congenital patients have special limbs and devices to aid in the participation of sports and recreational activities.

Within science fiction, and, more recently, within the scientific community, there has been consideration given to using advanced prostheses to replace healthy body parts with artificial mechanisms and systems to improve function. The morality and desirability of such technologies are being debated by transhumanists, other ethicists, and others in general.[135][136][137][138] Body parts such as legs, arms, hands, feet, and others can be replaced.

The first experiment with a healthy individual appears to have been that by the British scientist Kevin Warwick. In 2002, an implant was interfaced directly into Warwick's nervous system. The electrode array, which contained around a hundred electrodes, was placed in the median nerve. The signals produced were detailed enough that a robot arm was able to mimic the actions of Warwick's own arm and provide a form of touch feedback again via the implant.[139]

The DEKA company of Dean Kamen developed the "Luke arm", an advanced nerve-controlled prosthetic. Clinical trials began in 2008,[140] with FDA approval in 2014 and commercial manufacturing by the Universal Instruments Corporation expected in 2017. The price offered at retail by Mobius Bionics is expected to be around $100,000.[141]

Further research in April 2019, there have been improvements towards prosthetic function and comfort of 3D-printed personalized wearable systems. Instead of manual integration after printing, integrating electronic sensors at the intersection between a prosthetic and the wearer's tissue can gather information such as pressure across wearer's tissue, that can help improve further iteration of these types of prosthetic.[142]

Oscar Pistorius

[edit]

In early 2008, Oscar Pistorius, the "Blade Runner" of South Africa, was briefly ruled ineligible to compete in the 2008 Summer Olympics because his transtibial prosthesis limbs were said to give him an unfair advantage over runners who had ankles. One researcher found that his limbs used twenty-five percent less energy than those of a non-disabled runner moving at the same speed. This ruling was overturned on appeal, with the appellate court stating that the overall set of advantages and disadvantages of Pistorius' limbs had not been considered.

Pistorius did not qualify for the South African team for the Olympics, but went on to sweep the 2008 Summer Paralympics, and has been ruled eligible to qualify for any future Olympics.[citation needed] He qualified for the 2011 World Championship in South Korea and reached the semi-final where he ended last timewise, he was 14th in the first round, his personal best at 400m would have given him 5th place in the finals. At the 2012 Summer Olympics in London, Pistorius became the first amputee runner to compete at an Olympic Games.[143] He ran in the 400 metres race semi-finals,[144][145][146] and the 4 × 400 metres relay race finals.[147] He also competed in 5 events in the 2012 Summer Paralympics in London.[148]

Design considerations

[edit]

There are multiple factors to consider when designing a transtibial prosthesis. Manufacturers must make choices about their priorities regarding these factors.

Performance

[edit]

Nonetheless, there are certain elements of socket and foot mechanics that are invaluable for the athlete, and these are the focus of today's high-tech prosthetics companies:

  • Fit – athletic/active amputees, or those with bony residua, may require a carefully detailed socket fit; less-active patients may be comfortable with a 'total contact' fit and gel liner
  • Energy storage and return – storage of energy acquired through ground contact and utilization of that stored energy for propulsion
  • Energy absorption – minimizing the effect of high impact on the musculoskeletal system
  • Ground compliance – stability independent of terrain type and angle
  • Rotation – ease of changing direction
  • Weight – maximizing comfort, balance and speed
  • Suspension – how the socket will join and fit to the limb

Other

[edit]

The buyer is also concerned with numerous other factors:

  • Cosmetics
  • Cost
  • Ease of use
  • Size availability

Design for Prosthetics

[edit]

A key feature of prosthetics and prosthetic design is the idea of "designing for disabilities." This might sound like a good idea in which people with disabilities can participate in equitable design but this is unfortunately not true. The idea of designing for disabilities is first problematic because of the underlying meaning of disabilities. It tells amputees that there is a right and wrong way to move and walk and that if amputees are adapted to the surrounding environment by their own means, then that is the wrong way. Along with that underlying meaning of disabilities, many people designing for disabilities are not actually disabled. "Design for disability" from these experiences, takes disability as the object - with the feeling from non-disabled designers that they have properly learned about their job from their own simulation of the experience. The simulation is misleading and does a disservice to disabled people - so the design that flows from this is highly problematic. Engaging in disability design should be… with, ideally, team members who have the relevant disability and are part of communities that matter to the research.[149] This leads to people, who do not know what the day-to-day personal experiences are, designing materials that do not meet the needs or hinder the needs of people with actual disabilities.

Cost and source freedom

[edit]

High-cost

[edit]

In the United States, a typical prosthetic limb costs anywhere between $15,000 and $90,000, depending on the type of limb desired by the patient. With medical insurance, a patient will typically pay 10%–50% of the total cost of a prosthetic limb, while the insurance company will cover the rest of the cost. The percent that the patient pays varies on the type of insurance plan, as well as the limb requested by the patient.[150] In the United Kingdom, much of Europe, Australia and New Zealand the entire cost of prosthetic limbs is met by state funding or statutory insurance. For example, in Australia prostheses are fully funded by state schemes in the case of amputation due to disease, and by workers compensation or traffic injury insurance in the case of most traumatic amputations.[151] The National Disability Insurance Scheme, which is being rolled out nationally between 2017 and 2020 also pays for prostheses.

Transradial (below the elbow amputation) and transtibial prostheses (below the knee amputation) typically cost between US $6,000 and $8,000, while transfemoral (above the knee amputation) and transhumeral prosthetics (above the elbow amputation) cost approximately twice as much with a range of $10,000 to $15,000 and can sometimes reach costs of $35,000. The cost of an artificial limb often recurs, while a limb typically needs to be replaced every 3–4 years due to wear and tear of everyday use. In addition, if the socket has fit issues, the socket must be replaced within several months from the onset of pain. If height is an issue, components such as pylons can be changed.[152]

Not only does the patient need to pay for their multiple prosthetic limbs, but they also need to pay for physical and occupational therapy that come along with adapting to living with an artificial limb. Unlike the reoccurring cost of the prosthetic limbs, the patient will typically only pay the $2000 to $5000 for therapy during the first year or two of living as an amputee. Once the patient is strong and comfortable with their new limb, they will not be required to go to therapy anymore. Throughout one's life, it is projected that a typical amputee will go through $1.4 million worth of treatment, including surgeries, prosthetics, as well as therapies.[150]

Low-cost

[edit]

Low-cost above-knee prostheses often provide only basic structural support with limited function. This function is often achieved with crude, non-articulating, unstable, or manually locking knee joints. A limited number of organizations, such as the International Committee of the Red Cross (ICRC), create devices for developing countries. Their device which is manufactured by CR Equipments is a single-axis, manually operated locking polymer prosthetic knee joint.[153]

Table. List of knee joint technologies based on the literature review.[87]

Name of technology (country of origin) Brief description Highest level of

evidence

ICRC knee (Switzerland) Single-axis with manual lock Independent field
ATLAS knee (UK) Weight-activated friction Independent field
POF/OTRC knee (US) Single-axis with ext. assist Field
DAV/Seattle knee (US) Compliant polycentric Field
LIMBS International M1 knee (US) Four-bar Field
JaipurKnee (India) Four-bar Field
LCKnee (Canada) Single-axis with automatic lock Field
None provided (Nepal) Single-axis Field
None provided (New Zealand) Roto-molded single-axis Field
None provided (India) Six-bar with squatting Technical development
Friction knee (US) Weight-activated friction Technical development
Wedgelock knee (Australia) Weight-activated friction Technical development
SATHI friction knee (India) Weight-activated friction Limited data available
Low-cost above-knee prosthetic limbs: ICRC Knee (left) and LC Knee (right)

A plan for a low-cost artificial leg, designed by Sébastien Dubois, was featured at the 2007 International Design Exhibition and award show in Copenhagen, Denmark, where it won the Index: Award. It would be able to create an energy-return prosthetic leg for US $8.00, composed primarily of fiberglass.[154]

Prior to the 1980s, foot prostheses merely restored basic walking capabilities. These early devices can be characterized by a simple artificial attachment connecting one's residual limb to the ground.

The introduction of the Seattle Foot (Seattle Limb Systems) in 1981 revolutionized the field, bringing the concept of an Energy Storing Prosthetic Foot (ESPF) to the fore. Other companies soon followed suit, and before long, there were multiple models of energy storing prostheses on the market. Each model utilized some variation of a compressible heel. The heel is compressed during initial ground contact, storing energy which is then returned during the latter phase of ground contact to help propel the body forward.

Since then, the foot prosthetics industry has been dominated by steady, small improvements in performance, comfort, and marketability.

With 3D printers, it is possible to manufacture a single product without having to have metal molds, so the costs can be drastically reduced.[155]

Jaipur foot, an artificial limb from Jaipur, India, costs about US$40.

Open-source robotic prosthesis

[edit]
Star Wars themed "Hero Arm" by Open Bionics

There is currently an open-design Prosthetics forum known as the "Open Prosthetics Project". The group employs collaborators and volunteers to advance Prosthetics technology while attempting to lower the costs of these necessary devices.[156] Open Bionics is a company that is developing open-source robotic prosthetic hands. They utilize 3D printing to manufacture the devices and low-cost 3D scanners to fit them onto the residual limb of a specific patient. Open Bionics' use of 3D printing allows for more personalized designs, such as the "Hero Arm" which incorporates the users favourite colours, textures, and even aesthetics to look like superheroes or characters from Star Wars with the aim of lowering the cost. A review study on a wide range of printed prosthetic hands found that 3D printing technology holds a promise for individualised prosthesis design, is cheaper than commercial prostheses available on the market, and is more expensive than mass production processes such as injection molding. The same study also found that evidence on the functionality, durability and user acceptance of 3D printed hand prostheses is still lacking.[157]

Low-cost prosthetics for children

[edit]
Artificial limbs for a juvenile thalidomide survivor 1961–1965

In the USA an estimate was found of 32,500 children (<21 years) had a major paediatric amputation, with 5,525 new cases each year, of which 3,315 congenital.[158]

Carr et al. (1998) investigated amputations caused by landmines for Afghanistan, Bosnia and Herzegovina, Cambodia and Mozambique among children (<14 years), showing estimates of respectively 4.7, 0.19, 1.11 and 0.67 per 1000 children.[159] Mohan (1986) indicated in India a total of 424,000 amputees (23,500 annually), of which 10.3% had an onset of disability below the age of 14, amounting to a total of about 43,700 limb deficient children in India alone.[160]

Few low-cost solutions have been created specially for children. Examples of low-cost prosthetic devices include:

Pole and crutch

[edit]

This hand-held pole with leather support band or platform for the limb is one of the simplest and cheapest solutions found. It serves well as a short-term solution, but is prone to rapid contracture formation if the limb is not stretched daily through a series of range-of motion (RoM) sets.[84]

Bamboo, PVC or plaster limbs

[edit]

This also fairly simple solution comprises a plaster socket with a bamboo or PVC pipe at the bottom, optionally attached to a prosthetic foot. This solution prevents contractures because the knee is moved through its full RoM. The David Werner Collection, an online database for the assistance of disabled village children, displays manuals of production of these solutions.[161]

Adjustable bicycle limb

[edit]

This solution is built using a bicycle seat post up side down as foot, generating flexibility and (length) adjustability. It is a very cheap solution, using locally available materials.[162]

Sathi Limb

[edit]

It is an endoskeletal modular lower limb from India, which uses thermoplastic parts. Its main advantages are the small weight and adaptability.[84]

Monolimb

[edit]

Monolimbs are non-modular prostheses and thus require more experienced prosthetist for correct fitting, because alignment can barely be changed after production. However, their durability on average is better than low-cost modular solutions.[163]

Cultural and social theory perspectives

[edit]

A number of theorists have explored the meaning and implications of prosthetic extension of the body. Elizabeth Grosz writes, "Creatures use tools, ornaments, and appliances to augment their bodily capacities. Are their bodies lacking something, which they need to replace with artificial or substitute organs?...Or conversely, should prostheses be understood, in terms of aesthetic reorganization and proliferation, as the consequence of an inventiveness that functions beyond and perhaps in defiance of pragmatic need?"[164] Elaine Scarry argues that every artifact recreates and extends the body. Chairs supplement the skeleton, tools append the hands, clothing augments the skin.[165] In Scarry's thinking, "furniture and houses are neither more nor less interior to the human body than the food it absorbs, nor are they fundamentally different from such sophisticated prosthetics as artificial lungs, eyes and kidneys. The consumption of manufactured things turns the body inside out, opening it up to and as the culture of objects."[166] Mark Wigley, a professor of architecture, continues this line of thinking about how architecture supplements our natural capabilities, and argues that "a blurring of identity is produced by all prostheses."[167] Some of this work relies on Freud's earlier characterization of man's relation to objects as one of extension.

Negative social implications

[edit]

Prosthetics play a vital role in how a person perceives themselves and how other people perceive them. The ability to conceal such use enabled participants to ward off social stigmatization that in turn enabled their social integration and the reduction of emotional problems surrounding such disability.[168] People that lose a limb first have to deal with the emotional result of losing that limb. Regardless of the reasons for amputation, whether due to traumatic causes or as a consequence of illness, emotional shock exists. It may have a smaller or larger amplitude depending on a variety of factors such as patient age, medical culture, medical cause, etc. As a result of amputation, the research participants' reports were loaded with drama. The first emotional response to amputation was one of despair, a severe sense of self-collapse, something almost unbearable.[169] Emotional factors are just a small part of looking at social implications. Many people who lose a limb may have lots of anxiety surrounding prosthetics and their limbs. After surgery, for an extended period of time, the interviewed patients from the National Library of Medicine noticed the appearance and increase of anxiety. A lot of negative thoughts invaded their minds. Projections about the future were grim, marked by sadness, helplessness, and even despair. Existential uncertainty, lack of control, and further anticipated losses in one's life due to amputation were the primary causes of anxiety and consequently ruminations and insomnia.[169] From losing a leg and getting a prosthetics there were also many factors that can happen including anger and regret. The amputation of a limb is associated not only with physical loss and change in body image but also with an abrupt severing in one's sense of continuity. For participants with amputation as a result of physical trauma the event is often experienced as a transgression and can lead to frustration and anger.[169]

Ethical concerns

[edit]

There are also many ethical concerns about how the prosthetics are made and produced. A wide range of ethical issues arise in connection with experiments and clinical usage of sensory prostheses: animal experimentation; informed consent, for instance, in patients with a locked-in syndrome that may be alleviated with a sensory prosthesis; unrealistic expectations of research subjects testing new devices.[170] How prosthetics come to be and testing of the usability of the device is a major concern in the medical world. Although many positives come when a new prosthetic design is announced, how the device got to where it is leads to some questioning the ethics of prosthetics.

Debates

[edit]

There are also many debates among the prosthetic community about whether they should wear prosthetics at all. This is sparked by whether prosthetics help in day-to-day living or make it harder. Many people have adapted to their loss of limb making it work for them and do not need a prosthesis in their life. Not all amputees will wear a prosthesis. In a 2011 national survey of Australian amputees, Limbs 4 Life found that 7 percent of amputees do not wear a prosthesis, and in another Australian hospital study, this number was closer to 20 percent.[171] Many people report being uncomfortable in prostheses and not wanting to wear them, even reporting that wearing a prosthetic is more cumbersome than not having one at all. These debates are natural among the prosthetic community and help us shed light on the issues that they are facing.

Notable users of prosthetic devices

[edit]

Mythological

[edit]

Nuada, mythical king loses his arm in battle but is given a silver arm in its place.

Visphala, mentioned in the Rigveda as losing a leg in battle, but being given "leg of iron"

See also

[edit]

References

[edit]
[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia
from Grokipedia
A prosthesis is an artificial device designed to replace a missing body part or to improve the function of a damaged one, often necessitated by amputation due to trauma, disease, or congenital absence. These devices aim to restore mobility, dexterity, or other physiological functions, with historical examples tracing back to ancient civilizations where rudimentary wooden or metal limbs were crafted from materials like cartonnage, leather, and bronze. Prostheses encompass a range of types, including upper and lower limb variants, as well as internal implants for joints or organs, categorized by control mechanisms such as body-powered systems using cables and harnesses, myoelectric devices powered by muscle electrical signals, and hybrid models combining both. Body-powered prostheses rely on mechanical leverage from the user's residual limb or movements, while myoelectric ones employ surface electrodes to detect electromyographic signals for precise control, enabling more gestures in upper-extremity applications. Passive prostheses provide cosmetic restoration without active function, serving primarily aesthetic or stabilizing roles. Advancements in prosthetic technology have accelerated with materials like and carbon fiber for durability and lightweight design, alongside innovations in neural interfaces and for intuitive control, allowing users to achieve biomimetic patterns in lower-limb devices. Recent developments include prostheses driven by direct modulation, which enhance sensory feedback and reduce energy expenditure during ambulation, marking a shift toward integration with the body's neural pathways for more seamless functionality. These progressions, rooted in empirical biomechanical research, underscore prostheses' role in mitigating impacts, though challenges persist in and long-term adaptability across diverse user physiologies.

Historical Development

Ancient and Pre-Modern Prosthetics

The earliest known prosthetic device is an artificial eye discovered in the Burnt City of Shahr-i Sokhta in southeastern Iran, dating to approximately 2900–2800 BCE. Crafted from bitumen paste mixed with animal fat and overlaid with a thin gold cap, it was found in the socket of a female skull, suggesting use for both cosmetic and possibly symbolic purposes in a pre-literate society along ancient trade routes. This artifact predates other limb prosthetics and highlights early attempts at facial restoration, though its functionality was limited to maintaining ocular appearance rather than vision. Limb prosthetics emerged later in , with one of the oldest examples being a wooden big prosthesis from , dated to around 950 BCE and discovered on a near . Made from wood carved to articulate with the foot's joints and secured with leather straps, biomechanical tests on replicas confirm it enabled wearers to walk effectively by mimicking natural flexion during . Such devices, likely used by elites given the craftsmanship, reflect rudimentary anatomical observation but were constrained by materials prone to wear and high post-amputation infection rates without knowledge. By the 3rd century BCE, prosthetic legs appeared in both Roman and Chinese contexts. The Capua leg, excavated from a grave in , , around 300 BCE, consisted of a bronze sheath with iron hinges and wooden core, designed as a below-knee replacement fastened by straps for basic mobility. Similarly, a wooden lower-leg prosthesis from the Shengjindian cemetery near , (ca. 300–200 BCE), attached via pegs to the residual limb, indicates parallel innovations in for supporting weight-bearing after trauma, though preservation issues limit precise functional analysis. These relied on simple mechanical joints and organic materials like wood and leather, offering passive support amid frequent battlefield amputations but succumbing to decay and poor fit due to absent biomechanical principles. In medieval and , prosthetics advanced modestly for warriors, exemplified by the iron hand of German knight , fitted after injury in 1504. This mechanical prosthesis, articulated with springs and levers operable by the left hand, allowed gripping reins, shields, or weapons, enabling continued knighthood into old age. French surgeon further refined designs in the mid-16th century, introducing upper- and lower-limb prostheses with catches, springs, and articulated joints for wounded soldiers, emphasizing functionality over mere cosmetics while using iron, wood, and leather. Pre-modern limitations persisted, including from unsterile surgery—amputation mortality exceeded 50%—and devices' weight, which restricted prolonged use without modern fixation or control. These innovations prioritized restoration for combat roles in feudal societies, underscoring causal links between warfare, survival needs, and empirical crafting over theoretical .

19th and Early 20th Century Advances

The (1861–1865) significantly advanced prosthetic limb development due to the high volume of amputations, estimated at approximately 60,000 procedures, which created unprecedented demand for functional replacements. This surge prompted innovations in mechanical design, including the introduction of articulated joints for improved mobility; for instance, Confederate veteran James E. Hanger patented the "Hanger Limb" in 1863, a wooden leg featuring rubber components in the ankle joint for shock absorption and heel cushioning, marking an early shift toward more durable, user-adaptable devices. U.S. government support, via pensions and contracts, further incentivized manufacturers to produce adjustable prosthetics with hinged knees and elbows, reducing reliance on rigid peg legs. In , mid-19th-century efforts emphasized articulated mechanisms for below-knee and above-knee prostheses, with designs incorporating steel springs and brass hinges to mimic natural ; a notable example is the Victorian-era artificial arm from 1850–1910, which allowed flexion via spring release and wrist rotation. French and British limb-makers refined passive articulated legs in the 1850s–1860s, using leather sockets and metal rods for weight-bearing stability, though these remained body-powered without external energy sources. These incremental improvements were driven by biomechanical observations from amputee feedback, prioritizing passive mechanical functionality over cosmetics initially. By the early , around 1900–1912, materials like aluminum were integrated for lighter weight, as seen in William Robert Grossmith's mid-19th-century wood-aluminum arm evolving into Marcel Desoutter's 1912 all-aluminum leg prosthesis, which reduced overall mass while maintaining structural integrity. Rubber continued to feature in joints and padding for enhanced comfort and durability, with pre-World War I devices remaining predominantly passive, relying on cables, springs, and user leverage rather than motors. The era's spikes from conflicts spurred basic , transitioning artisanal custom fits to semi-mass-produced models adaptable to anatomies, though variability in socket fit often led to mechanical .

Post-WWII Innovations

The influx of over 14,000 U.S. military amputees from necessitated rapid advancements in prosthetic care, prompting the Veterans Administration (VA) to establish dedicated research programs. In 1948, authorized annual funding of $1 million for VA-led prosthetic and rehabilitation research, focusing on empirical testing with veteran cohorts to improve fit, durability, and functionality. This investment catalyzed the development of standardized, modular components, allowing for customizable assemblies that enhanced long-term mobility; VA hospital records from the late 1940s and 1950s documented ambulation improvements in up to 80% of lower-limb amputees fitted with refined body-powered systems featuring shoulder harnesses and friction joints. Post-war designs shifted toward lighter materials and better interface technologies, building on wartime production scales. While wood-and-leather limbs predominated immediately after , aluminum alloys were increasingly integrated into structural elements like pylons and joints by the early , reducing weight by approximately 20-30% compared to predecessors and enabling greater endurance during daily activities. Harness systems evolved with adjustable straps and cineplastic attachments—surgically implanted muscle-tendon levers—for upper-limb prostheses, as tested in VA clinics where veteran feedback drove iterative refinements for causal factors like skin breakdown and . By 1949, the VA had set up 30 multidisciplinary amputee centers nationwide, aggregating data that linked modular designs to reduced rejection rates and higher reintegration among users. Early powered prototypes emerged amid competition, with Soviet researchers pioneering myoelectric control in the 1950s. Experiments by teams in , culminating in Alexander Kobrinski's "Russian Hand" around 1957-1960, utilized surface electromyographic signals from residual muscles to actuate basic grip functions via transistor-based amplifiers, marking a departure from purely mechanical systems despite initial bulk and battery limitations. These developments, though not widely deployed until the 1960s, influenced U.S. VA efforts in externally powered limbs, prioritizing empirical validation through amputee trials to address real-world causal barriers like signal noise and power efficiency.

Recent Technological Milestones (1980s-Present)

In the , commercial myoelectric prosthetic arms emerged as a significant advancement, enabling control via muscle signals without mechanical cables. The Arm, developed at the and introduced in 1981, became a benchmark for above-elbow amputees, featuring multiple and microprocessor-based control validated through clinical use and iterative improvements. Osseointegration techniques advanced in the 1990s, allowing direct skeletal attachment of prostheses to improve stability and reduce socket-related issues. Per Olof Brånemark and colleagues initiated clinical trials in in 1990 for transfemoral amputees, achieving long-term bone-implant integration with fixtures, as demonstrated in prospective studies showing enhanced prosthetic function and patient satisfaction over socket-based systems. The 2010s saw the rise of 3D-printed prosthetics, democratizing access through low-cost, customizable designs. The e-NABLE community, formalized around 2013, facilitated global volunteer printing and assembly of mechanical hands, with early prototypes like the 2011 design for a gaining traction; by 2015, myoelectric variants were prototyped, supported by empirical feedback from thousands of devices distributed worldwide. DARPA's RE-NET program, launched in 2010, developed reliable peripheral nerve interfaces for prosthetic control and sensory feedback, with demonstrations by 2013 using nerve and muscle signals in amputees, leading to clinical evaluations through the and influencing commercial neural interfaces into the . Recent years have integrated AI for adaptive control and brain-computer interfaces (BCIs) for neural feedback. AI-enhanced prototypes, such as pediatric arms using for real-time adjustment to user patterns, entered development phases by 2025, with algorithms processing biosignals for intuitive operation in lab trials. In January 2025, researchers reported a fine-tuned BCI delivering realistic tactile sensations via timed brain stimulation, enabling prosthetic users to discern and texture in controlled experiments, marking progress toward sensory restoration.

Classification and Types

Limb Prostheses

Limb prostheses are categorized by the anatomical level of and functional requirements, with devices addressing manipulation and reach, while lower limb devices prioritize and locomotion. Upper limb amputations include transradial (below-) and transhumeral (above-) levels, where transradial prostheses retain function for improved control, whereas transhumeral designs must incorporate joints to compensate for lost native articulation. Lower limb amputations comprise transtibial (below-) and transfemoral (above-) levels, with transtibial prostheses benefiting from preserved stability for better efficiency compared to transfemoral ones, which require simulated and mechanics to manage higher biomechanical demands like shock absorption and propulsion. Globally, lower limb amputations predominate, accounting for approximately 91% of cases in recent U.S. projections, driven primarily by vascular diseases such as rather than trauma for upper limbs. This disparity reflects causal factors like leading to tissue necrosis in the legs, contrasting with upper limb losses often from accidents preserving vascular integrity in residuals. Biomechanically, lower limb prostheses must withstand compressive forces exceeding body weight during stance phase, demanding robust alignment to prevent compensatory deviations, while upper limb devices emphasize lightweight construction to minimize fatigue in repetitive tasks. For prostheses, terminal devices typically feature hooks or hands; hooks offer advantages in and reduced weight—delivering higher pinch forces with lower activation requirements—making them suitable for heavy-duty tasks, though less aesthetically versatile than multi-fingered hands which enhance dexterity for fine manipulation at the cost of added mass and complexity. In pediatric cases, prostheses incorporate modular components and adjustable sockets to accommodate rapid growth, with replacements often needed every 6-12 months, yet abandonment rates reach 45% for body-powered models due to ill fit and discomfort, frequently worsened by comorbid vascular conditions impairing tolerance and socket interface stability.

Organ and Sensory Prostheses

Organ prostheses encompass implantable devices designed to replace or augment the function of vital internal organs, primarily focusing on the cardiovascular system. Cardiac pacemakers, first successfully implanted in humans in the late 1950s, deliver electrical impulses to regulate heart rhythm in patients with bradycardia or conduction disorders. The first clinically viable implantable pacemaker was developed by VA researchers and implanted in 1960, marking a pivotal advancement in preventing life-threatening arrhythmias. These devices, typically comprising a pulse generator and leads, have evolved to include dual-chamber models that synchronize atrial and ventricular contractions, with modern units lasting 5-15 years before battery replacement. Artificial hearts, such as the Jarvik-7 total artificial heart implanted on December 2, 1982, into patient Barney Clark at the University of Utah, represent more radical interventions for end-stage heart failure. The Jarvik-7, pneumatically driven polyurethane pumps connected to external compressors, sustained Clark for 112 days as a bridge to transplantation, though complications including thromboembolism and hemolysis limited long-term viability. Sensory prostheses target restoration of hearing and vision through direct neural , bypassing damaged peripheral structures. Cochlear implants, approved by the FDA in 1984 for the / single-electrode device in postlingually deaf adults, electrically stimulate the auditory nerve via an array inserted into the . These multichannel systems convert sound into patterned electrical signals, enabling open-set in many users, with clinical data showing improved auditory over hearing aids in severe-to-profound sensorineural loss cases. Ocular prostheses traditionally serve cosmetic purposes, such as acrylic shells fitted post-enucleation to mimic eye appearance without functional restoration. In contrast, retinal prostheses aim at partial vision recovery by implanting microelectrode arrays on or under the to stimulate surviving cells in conditions like or ; a 2025 Stanford-led trial demonstrated regained light perception and in advanced patients using a wireless subretinal implant. Integration challenges for these prostheses stem from and physiological interactions, including risks of in blood-contacting devices like artificial hearts, where on elements promotes clot formation despite anticoagulation. Immune-mediated rejection is less prevalent in fully synthetic implants but arises in hybrid designs incorporating biologics, necessitating that elevates susceptibility. Empirical outcomes highlight causal trade-offs: while pacemakers achieve over 95% procedural success with low acute complication rates, artificial hearts face high morbidity from device-related s and strokes, underscoring the gap between short-term bridging and permanent replacement. Sensory implants similarly contend with variable efficacy tied to neural preservation; cochlear outcomes depend on residual auditory function, with around electrodes potentially degrading signal fidelity over time. These factors emphasize empirical validation over optimistic projections, as historical trials reveal underappreciated failure modes like device encapsulation reducing efficacy.

Materials and Design Principles

Core Materials and Their Mechanical Properties

, particularly , dominate structural components in load-bearing prostheses owing to their high strength, with endurance limits exceeding 500 MPa under cyclic loading, and superior that supports without eliciting significant inflammatory responses. These alloys exhibit a of approximately 110 GPa, providing stiffness for weight-bearing applications, though this exceeds cortical bone's range of 6-30 GPa, potentially inducing stress shielding and over time. resistance remains robust in physiological environments, with minimal degradation observed for up to 10 years, but cracks can initiate at surface defects, contributing to failure rates of nearly 90% in high-stress implants like hip prostheses. Carbon fiber reinforced polymers (CFRPs) offer a counterbalance through their anisotropic properties, achieving strength-to-weight ratios up to five times that of —specific tensile strengths often surpassing 2 GPa/(g/cm³)—while maintaining densities around 1.5-1.8 g/cm³ for reduced user . These composites provide tailored via orientation, with moduli adjustable to 50-200 GPa to approximate and minimize stress concentrations, alongside inherent radiolucency for imaging compatibility. is favorable, with low in implantation studies, though delamination under shear stresses poses a risk absent in monolithic metals. Polymers such as medical-grade silicones serve in interface layers, prized for formulations that resist protein adsorption and bacterial , ensuring minimal reactions in prolonged contact. Their elastomeric nature yields low moduli (0.5-5 MPa) for cushioning, coupled with tear strengths above 10 kN/m and abrasion resistance that supports 6-12 month lifespans under daily ambulation, beyond which hardening and cracking necessitate replacement. Emerging use of recycled polymers and composites promotes by repurposing waste plastics into viable sockets, achieving cost reductions of up to 90% in low-resource settings, yet empirical tests reveal 20-30% inferior life versus virgin materials due to inconsistent alignment and residual contaminants. This trade-off underscores that while recyclability curtails virgin resource demands, durability benchmarks—such as 10-year structural integrity—favor established alloys and CFRPs for high-performance demands.
MaterialYoung's Modulus (GPa)Key Strength MetricDensity (g/cm³)Primary Trade-off
~110Fatigue limit >500 MPa~4.43Stress shielding vs.
CFRP50-200 (anisotropic)Specific tensile >2 GPa/(g/cm³)1.5-1.8 risk
(liners)0.001-0.005Tear strength >10 kN/m~1.1Limited lifespan (6-12 months)

Interface and Socket Design

The prosthetic socket forms the essential interface between the residual limb and the prosthesis, transmitting forces from the device to the soft tissues while aiming to achieve uniform pressure distribution that avoids localized peaks exceeding tissue tolerance thresholds, thereby preventing dermatological complications such as friction-induced ulcers and pressure sores. Finite element modeling studies confirm that socket geometry directly influences interfacial stresses, with suboptimal designs elevating shear and compressive loads on vulnerable areas like bony prominences. Sockets are custom-fabricated to match individual residual limb morphology, traditionally via plaster-of-Paris casts to capture contours, or through optical or scans digitized for and manufacturing (CAD/CAM) processes developed in the , which allow iterative virtual modifications for enhanced precision and reproducibility compared to manual rectification. These digital methods reduce fabrication errors and enable patient-specific optimizations, such as reliefs over sensitive regions, minimizing the iterative trial-and-error adjustments common in conventional workflows. Inadequate socket fit, characterized by uneven pressure mapping, ranks as the predominant barrier to effective rehabilitation, with 65.7% of clinicians and 48.0% of amputees identifying it as the chief source of frustration and limitation in lower limb prosthetic use. Empirical assessments using instrumented sockets reveal that poor accommodation of load distribution correlates with elevated risks of skin breakdown, as repetitive shear forces from misalignment or pistoning exacerbate tissue trauma in the absence of adaptive interfaces. To maintain suspension and mitigate pistoning—the relative motion between limb and socket—systems such as anatomical harnesses with straps, liners creating negative pressure seals, or elevated mechanisms are employed, directly addressing causal factors like diurnal residual limb volume fluctuations of up to 10% or atrophy-driven reductions reaching 35% in transtibial cases post-amputation. Volume changes stem from physiological processes including initial resolution and long-term muscular , which loosen the fit unless countered by suspension that stabilizes the interface and promotes lymphatic drainage under controlled . Contemporary designs incorporate adjustable features, such as modular liners or pneumatic bladders, to dynamically respond to volume variations, evidenced by reduced refit frequency and improved user-reported comfort in clinical evaluations of transtibial sockets. Sensor-integrated interfaces further enable real-time monitoring, facilitating evidence-based refinements that prioritize tissue viability over static geometries.

Structural and Terminal Components

Polycentric knee mechanisms in lower-limb prostheses feature multiple axes of , typically in four-bar or multi-bar configurations, to enhance stance-phase stability by dynamically shifting the instantaneous center of posteriorly, thereby approximating the kinematic path of the anatomical and reducing the risk of unintended flexion under load. These designs provide involuntary stability during weight acceptance without relying on advanced , making them suitable for users with moderate activity levels. Ankle mechanisms complement knee units through multi-link linkages or parallel structures, enabling controlled dorsiflexion and plantarflexion to facilitate heel-to-toe rollover and energy transfer in . Terminal components, such as prosthetic feet, function as distal end-effectors with kinematic profiles optimized for shock absorption and propulsion; passive energy-storing variants, often constructed from carbon fiber composites, deform under load to store and release up to 90-95% during push-off, as seen in designs like the Cheetah Xceed blade for sprinting applications. These outperform rigid or cushioned heels in dynamic scenarios by mimicking the ankle's role in forward progression, though they demand precise alignment to avoid torsional stress. Structural and terminal components undergo rigorous empirical validation via standards like ISO 10328, which mandates static proof-loading to 1.5-3 times body weight and cyclic simulating millions of steps to assess under compound axial, torsional, and bending forces. Passive terminals excel in simplicity, lightness, and reliability for daily use, minimizing mechanical failure points, whereas active designs integrate powered joints for variable compliance but introduce trade-offs in and resistance. For upper-limb prostheses, terminal devices such as voluntary-opening hooks or multi-articulated hands prioritize grasp , with modular finger linkages allowing adaptive positioning for tasks, though passive iterations limit motion to user-manipulated . Adaptations for varied terrains include compliant structures in feet for uneven surfaces, derived from kinematic data emphasizing reduced peak pressures and improved roll-over efficiency.

Control and Actuation Systems

Body-Powered and Mechanical Controls

Body-powered prosthetic controls utilize harnesses and cables actuated by the user's residual musculature, typically through shoulder abduction, humeral flexion, or scapular motion, to transmit force to terminal devices such as hooks or hands. These systems operate without external power sources, relying on mechanical linkages like Bowden cables for control. Transradial configurations often employ a single cable, while transhumeral setups require dual cables to manage elbow and terminal device functions. Terminal devices in these systems commonly feature voluntary closing (VC) or voluntary opening (VO) grippers. VC devices remain open at rest and close proportionally to applied cable tension, enabling grip force modulation based on user effort; VO devices, conversely, require tension to open from a default closed position, with elastic bands or springs providing closure. Proprioceptive feedback arises directly from cable displacement and tension, allowing users to sense grasp width and pinch force without electronic sensors. These controls offer empirical advantages in reliability and simplicity, including absence of battery dependency, reduced weight (often under 500 grams for upper-limb systems), and enhanced durability in demanding environments, with components resisting moisture and dirt better than electrically powered alternatives. Studies indicate body-powered hooks maintain functionality over extended periods, with users reporting preferences for their robustness in heavy-duty tasks over more complex devices. Cost-effectiveness is evident, as fabrication and maintenance expenses remain lower, supporting broader accessibility in resource-limited settings. Limitations include harness-induced skin irritation and chafing from prolonged strap , necessitating frequent adjustments. The mechanical demands impose upper-body strain, as generating sufficient cable force (often 20-50 Newtons for effective grasp) fatigues muscles during repetitive use. are constrained, typically to one (e.g., open/close) in the terminal device, limiting dexterity for multi-finger patterns or fine manipulation compared to anatomical hands.

Myoelectric and Electromechanical Systems

Myoelectric systems control prosthetic limbs by detecting electromyographic (EMG) signals from residual muscles using surface electrodes placed over the skin of the stump, typically targeting flexor and extensor muscle groups for contraction detection. These signals are amplified, filtered to remove noise such as motion artifacts, and processed to drive electromechanical actuators like DC motors or servomotors, enabling battery-powered operation independent of mechanical linkages. Signal processing involves rectification and integration for basic on-off control or advanced techniques like to classify multiple movement intentions from simultaneous EMG channels. Advances in algorithms, emerging in the , utilized supervised to decode complex EMG patterns, allowing for and multi-degree-of-freedom (DOF) movements beyond simple binary switching. These algorithms extract features such as time-domain or frequency spectra from EMG data, training classifiers like to map signals to specific grips or joint positions with accuracies often exceeding 90% in controlled tests. However, real-world performance degrades due to factors like shifts or environmental interference, necessitating adaptive recalibration. Empirical studies indicate myoelectric prostheses can enhance dexterity compared to body-powered alternatives, with enabling more natural multi-DOF control during , though gains are task-specific and users report higher compensatory movements in some scenarios. modes include signal disruption from sweat-induced changes in impedance, which alters EMG amplitude and increases , potentially leading to unintended activations or control loss. Commercial implementations, such as the Michelangelo hand introduced in the , demonstrate these principles with EMG-driven thumb opposition and seven grip patterns, supported by flexible wrist joints for improved functionality. Energy efficiency remains a constraint, with battery life typically ranging from 8 to 24 hours depending on usage intensity and DOF demands, as higher actuator counts increase power draw from rechargeable lithium-polymer cells. Ongoing optimizations focus on low-power microcontrollers and efficient motor drivers to extend operational time without compromising responsiveness.

Neural Interfaces and Brain-Computer Integration

![DARPA Revolutionizing Prosthetics][float-right] Targeted muscle reinnervation (TMR), pioneered by Todd A. Kuiken and Gregory A. Dumanian at Northwestern University in 2002, surgically reroutes residual peripheral nerves to denervated target muscles in the amputation stump, amplifying electromyographic signals for intuitive prosthetic control. This technique generates multiple independent EMG channels, enabling control of prostheses with up to six degrees of freedom, surpassing traditional single-site myoelectric systems that often limit users to basic grasp patterns. Clinical outcomes show TMR reduces prosthetic abandonment rates by improving signal reliability and also alleviates neuroma and phantom limb pain through nerve regeneration into functional muscle targets. Empirical data from patients indicate mastery of TMR-enhanced control within weeks, compared to months required for conventional myoelectric adaptation, due to the biomimetic mapping of neural intent to muscle activation. Direct peripheral interfaces extend TMR principles by implanting electrodes on or within bundles to record motor signals and deliver sensory feedback, as pursued in DARPA's RE-NET program launched in the early . These interfaces decode fascicular-level activity for precise limb control and stimulate afferents to restore touch sensation, achieving bidirectional communication absent in unidirectional systems. DARPA's HAPTIX initiative, initiated in 2014, further advanced haptic by integrating neural stimulation with prosthetic sensors, allowing users to perceive object texture and slippage in real-time trials. Cortical brain-computer interfaces (BCIs) provide higher-level intent decoding via intracortical implants, such as Utah arrays or flexible threads, targeting neurons to command complex prosthetic movements without reliance on peripheral signals. In clinical demonstrations at the , fine-tuned BCIs used timed intracortical microstimulation of the somatosensory cortex to evoke naturalistic tactile perceptions—distinguishing and gradients—through prosthetic hand sensors, markedly enhancing grasp accuracy over non-feedback systems. Integration of AI algorithms for neural signal decoding, refined between 2023 and , has improved haptic restoration by predicting and modulating feedback latency, though longevity remains constrained by encapsulation and , which degrade impedance and signal-to-noise ratios within months to years post-implantation. These risks underscore causal challenges in material , with chronic driving progressive signal loss despite initial high-fidelity performance.

Manufacturing and Biological Integration

Fabrication Techniques and Customization

Traditional fabrication of prosthetic components relies on subtractive methods, such as manual carving from foam or followed by with thermoset resins, or computer (CNC) milling from solid blocks of or metal to achieve precise geometries for sockets and terminal devices. CNC processes, integrated with CAD/CAM systems since the , enable repeatable accuracy within tolerances of 0.1 mm, supporting scalability for standardized parts while allowing modifications for individual limb shapes. Additive manufacturing, particularly via fused deposition modeling or , has emerged since the 2010s as a dominant technique for customization, using digital scans of the residual limb to generate patient-specific models that are layered from polymers like or carbon-fiber-reinforced filaments. This method reduces fabrication time by up to 75% relative to traditional casting and milling, facilitating on-site production in resource-limited settings through open-source designs. Cost analyses show 3D-printed upper-limb prosthetics achievable at $2,000 per unit, compared to $10,000–$50,000 for conventionally manufactured equivalents requiring specialized labor and materials. Customization protocols begin with or impression to define socket contours, followed by virtual simulations for alignment and iterative prototyping. Physical fitting incorporates alignment jigs to set joint angles and pylon heights, with subsequent dynamic adjustments during training to minimize pressure points. Clinical studies report patient satisfaction rates of 70–80% post-fitting when customization includes user input on design options, attributing improvements to better fit and reduced revisions. Hybrid approaches integrate for intricate lattice structures or prototypes with CNC for surface finishing, enabling complex geometries like lightweight endoskeletal frames that combine the precision of subtractive removal with additive . Such techniques enhance by allowing batch production of modular components tailored via software, as demonstrated in bionic hand where printed molds guide final assemblies.

Osseointegration and Surgical Attachments

provides a direct skeletal anchorage for prosthetic limbs by fostering a biomechanical lock between implants and living , allowing load transfer without reliance on sockets. This process relies on the of , particularly , which exhibits low modulus, high strength, and corrosion resistance conducive to bone apposition and remodeling under physiological loads. The concept originated from Per-Ingvar Brånemark's observations in the 1950s of bone marrow cells adhering to chambers during experiments, leading to the first clinical dental applications in 1965; adaptation to limb prosthetics began with the inaugural transfemoral implantation on May 15, 1990, in . Surgical attachment typically employs a two-stage protocol to minimize micromotion and promote stable integration. In the initial phase, an intramedullary stem—often threaded or fluted for primary stability—is inserted into the residual via cortical and reaming, followed by a healing period of 3-6 months for , monitored via radiographic evidence of bone condensation around the implant. The second stage involves exposing a abutment through the skin, enabling prosthetic attachment while sealing the skin-implant interface to reduce bacterial ingress. Clinical outcomes demonstrate high empirical stability, with rates of 92-98% in lower-limb applications over 5-year follow-ups, attributed to titanium's oxide layer facilitating adhesion and deposition. Advantages include elimination of socket-related complications such as pistoning, pressure sores, and volume fluctuations, yielding improved via direct mechanical feedback and enhanced efficiency, with studies reporting 20-30% increases in walking speed and reduced energy expenditure compared to socket prostheses. However, permanence introduces unique risks: complications at the site occur in 10-20% of cases, manifesting as or due to shear forces and formation, while periprosthetic infections—often staphylococcal—affect 2-5% of patients, potentially progressing to if untreated. Revision surgeries, necessitated by aseptic loosening or , arise in 5-10% of implants within 10 years, with causal factors including overload, poor quality, or inadequate initial fixation; deep infections, though rare (<3%), carry high morbidity and may require explantation. Ongoing refinements address infection vulnerabilities through surface modifications like coatings or antimicrobial-loaded abutments, enhancing and bacterial resistance without compromising . In the , preliminary trials have explored hybrid osseointegrated systems interfacing with peripheral via implanted electrodes, aiming to augment load transfer with sensory restoration, though long-term surgical outcomes remain under evaluation for scalability and complication profiles.

Muscle Reinnervation and Sensory Restoration

Targeted muscle reinnervation (TMR) redirects transected motor nerves from the amputation site to denervated residual muscles, promoting axonal regrowth into functional neuromuscular junctions that generate electromyographic signals for prosthetic control while mitigating formation. Initially developed in 2002 by Todd Kuiken for improving myoelectric prosthesis usability in upper-limb amputees, TMR incidentally revealed substantial relief benefits, with a randomized controlled trial demonstrating statistically significant reductions in and residual limb intensity compared to standard prevention techniques. Systematic reviews confirm TMR's efficacy in lowering post-amputation prevalence by over 70% in many cohorts, attributable to the causal mechanism of nerve end-targeting preventing aberrant sprouting and hypersensitivity. Sensory restoration extends TMR principles through targeted sensory reinnervation (TSR), which reroutes fascicles to reinnervate denervated skin flaps or grafts, enabling perceptual touch referral to the phantom limb. In TSR, selective fascicular identification ensures graded tactile discrimination, with case studies reporting restored light touch and pressure sensation in up to 80% of reinnervated sites post-upper extremity . Complementing this, regenerative peripheral interfaces (RPNI) involve autogenous free muscle grafts wrapped around transected to create stable, vascularized platforms for axonal regeneration, facilitating high-fidelity sensory feedback via implanted cuff electrodes that decode pressure and texture into afferent-like signals. Preclinical and early human data from RPNI show proportional sensory encoding with detection thresholds akin to native , reducing by restoring physiological input that counters maladaptive . Advanced implementations integrate implanted neural sensors directly into prosthetic interfaces for real-time haptic feedback, bypassing full reinnervation. Dermal sensory RPNI variants and intraneural electrodes deliver electrically evoked touch sensations, with 2025 pilot studies achieving interpretable feedback where users discriminate object textures and grasp forces via brain-perceived touch from prosthetic fingertips. These systems empirically enhance prosthetic embodiment and precision, as nerve regrowth into grafted targets provides amplified, modality-specific signals that correlate with reduced pain scores and improved through closed sensory-motor loops. Emerging synergies with brain-computer interfaces (BCI) enable closed-loop sensory-motor prosthetics, where TMR-augmented peripheral signals fuse with cortical decoding for bidirectional neural traffic. As of , hybrid prototypes combine TMR/RPNI with BCI to relay tactile data upstream, yielding naturalistic grip modulation and attenuation via real-time afferent restoration, though long-term stability remains under evaluation in ongoing trials. This integration causally addresses sensory deficits by reinstating causal chains of peripheral encoding to central perception, outperforming open-loop systems in functional metrics like error-free .

Performance and Human Factors

Functional Metrics and Empirical Outcomes

Lower-limb prosthesis users experience elevated metabolic costs during compared to able-bodied individuals, with increases varying by level due to biomechanical asymmetries and prosthetic limitations. Transtibial amputees typically incur a 10-30% higher expenditure for walking at self-selected speeds, attributable to reduced prosthetic ankle power and compensatory hiking on the intact limb. Transfemoral amputees face greater demands, with costs rising 30-60%, as socket suspension and knee- coordination further elevate oxygen consumption rates. Advanced components like energy-storing feet can mitigate costs by 5-10% in transtibial cases through improved return of , though gains diminish at higher speeds or on uneven .
Amputation LevelApproximate Energy Cost Increase During WalkingKey Causal Factors
Transtibial10-30%Prosthetic ankle stiffness, intact limb compensation
Transfemoral30-60%Socket interface losses, reduced hip extensor efficiency
Self-selected walking speeds for unilateral lower-limb amputees average 0.9-1.2 m/s, 20-40% slower than the 1.4 m/s norm for able-bodied adults, correlating with higher fall risks and onset during prolonged tasks. Endurance metrics, such as six-minute walk distances, reflect these deficits, with transtibial users covering 300-400 meters versus 500-600 meters for non-amputees, limited by cumulative energy deficits rather than peak capacity alone. Poorer outcomes at proximal levels stem from greater muscle mass loss and control demands, with bilateral cases showing compounded reductions up to 50% in speed and distance. Upper-limb prosthetic function, assessed via the Southampton Hand Assessment Procedure (SHAP), yields Index of Functionality scores averaging 65-70 for myoelectric hands, representing 65-70% of able-bodied norms (100) in prehensile tasks like pinching and grasping. Dexterity lags in speed and precision, with task completion times 2-6 times longer for activities such as relocation, influenced by reliability and grip pattern limitations. Multi-articulating designs improve SHAP scores by 10-15 points over single-grip models, yet baseline failures persist in fine motor demands like writing or tool use due to sensory feedback deficits. Longitudinal data indicate approximately 66% of lower-limb amputees return to some form of within 1-2 years, with rates dropping to 40-50% for proximal amputations owing to mobility constraints and job modifications. Component causally impacts these metrics; mismatched alignment increases energy costs by 5-15%, reducing daily step counts from 5,000-7,000 to below 3,000 in suboptimal fittings. Failure baselines include 20-30% prosthetic abandonment rates tied to inadequate durability or fit, underscoring that empirical gains remain sub-normal despite technological advances.

User Adaptation and Psychological Effects

Users adapt to prosthetic devices through cognitive integration into their , the internal representation of bodily posture and dynamics that guides movement. Empirical studies indicate that initial functional adaptation occurs rapidly, often within two weeks of consistent use, as the prosthesis begins to align with perceptual-motor expectations. Full embodiment, however, varies by individual factors such as age and amputation site, with older amputees experiencing prolonged psychological adjustment challenges due to entrenched body representations. Rejection rates stem not primarily from technological deficits but from mismatches in sensory feedback and , which disrupt ownership illusions necessary for seamless incorporation. Psychological effects include elevated risks of depression and anxiety post-amputation, with pooled prevalence rates around 34% among limb amputees, often linked to distortion and perceived dependency. Prosthesis provision correlates with reduced depression severity compared to non-users, as functional restoration mitigates helplessness by enabling independent mobility and daily tasks. Quality-of-life surveys, such as the and Prosthetics Users' Survey, reveal gains in autonomy and social participation for many users, though 44% report dissatisfaction tied to unmet expectations rather than device failure. These benefits underscore causal pathways where restored agency counters emotional decline, outweighing tech-centric explanations for persistent distress. Critiques of dependency models highlight risks of , where over-reliance on prosthetics may foster passive if rehabilitation emphasizes device function over intrinsic resilience. strategies like problem-focused predict better outcomes than avoidance, with empirical showing decreased anxiety-depressive symptoms post-prosthesis fitting in adherent users. Stigma's outsized role—exacerbated by societal perceptions of —often impedes acceptance more than prosthetic limitations, as evidenced by qualitative reports of improved when accompanies device use. Longitudinal tracking confirms that while initial depression peaks within months of , prosthesis-enabled drives recovery, prioritizing psychological readiness in rehabilitation protocols.

Limitations in Durability and Real-World Efficacy

Prosthetic components in lower limb devices demonstrate constrained durability, with sockets and structural elements often requiring replacement every 3 to 5 years owing to mechanical fatigue, residual limb volume fluctuations, and material degradation under cyclic loading. Prosthetic knees and feet, subjected to high-impact forces during ambulation, typically endure 3 to 7 years of use before failure, influenced by user weight, activity level, and gait asymmetry that accelerates joint wear. Liners and interfaces, in contact with skin and sweat, degrade faster, necessitating changes every 6 to 12 months to prevent irritation or slippage. Environmental exposures further compromise longevity, particularly for powered prosthetics where electronics and batteries succumb to water ingress, dirt accumulation, and humidity, inducing corrosion and electrical shorts. Surface (sEMG) sensors in myoelectric systems prove especially vulnerable to contaminants like dust, sweat, or moisture, diminishing signal reliability and overall control precision in non-sterile conditions. Such factors elevate repair frequency and costs, with non-waterproof designs failing rapidly in wet or dusty settings common to manual labor or outdoor activities. Real-world efficacy reveals stark disparities, with abandonment rates among prosthetic users in developing regions often exceeding 40%, attributed to functionality shortfalls in rugged terrains lacking infrastructure. In rural low-income contexts, devices optimized for urban pavements falter against mud, uneven paths, and , yielding lower adoption and higher discard compared to controlled urban trials where efficacy aligns closer to 60-70% sustained use. Limited access to skilled prosthetists exacerbates this, as field repairs prove infeasible for complex components, contrasting with higher persistence in serviced metropolitan areas. Discrepancies arise from lab-centric validation, where standardized benches simulate idealized loads but overlook real-world variabilities like impacts, biofluid exposure, or user , inflating perceived robustness. Empirical data from activity monitors show daily step counts and terrains diverging from protocol assumptions, causing field breakdowns not anticipated in isolated metrics. This reliance on contrived tests fosters causal mismatches, as prosthetic designs prioritize peak performance over resilient adaptation to heterogeneous demands, underscoring the need for ecologically valid assessments to bridge lab-field gaps.

Enhancements, Controversies, and Ethical Debates

Prosthetic Augmentation Beyond Restoration

Prosthetic augmentation seeks to equip users with capabilities surpassing pre-amputation function, leveraging powered actuators, advanced materials, and computational algorithms to enhance strength, speed, or precision. Carbon-fiber running blades in lower-limb prosthetics, for example, enable energy storage and return exceeding that of natural Achilles tendons, allowing double-leg amputees to achieve marathon completion times of 2:42:24, outperforming the average able-bodied recreational runner's pace of over 4 hours. Upper-limb bionic prosthetics with electric motors can generate grip forces up to 50-100 Newtons, comparable to or exceeding average human grip in sustained tasks, though limited by socket comfort and . Integration of for predictive movement control represents a frontier in augmentation, where models forecast intended motions from electromyographic signals milliseconds ahead of natural muscle activation, enabling smoother and faster responses. In 2024 developments, AI-driven prosthetics adapt in real-time to variations, reducing latency by up to 50% compared to traditional myoelectric systems and potentially allowing preemptive adjustments for enhanced agility. Empirical outcomes include cases where powered prosthetic systems, akin to exoskeleton-assisted limbs, amplify lifting capacity; users report handling loads perceived as 5% of actual weight, effectively multiplying effective strength by factors of 10-20 under controlled conditions, though full prosthetic integration remains constrained by biological interfaces. Such enhancements, however, introduce biomechanical imbalances, with studies noting elevated stress on contralateral joints—up to 20-30% increased loading—potentially hastening in residual limbs due to non-natural force transmission. Proponents in transhumanist discourse frame these technologies as evolutionary progress, arguing they liberate humans from biological constraints by amplifying innate potentials without inherent moral deviation. Critics counter that surpassing natural norms disrupts causal physiological equilibria, risking dependency on maintenance-intensive devices and eroding embodied human experience, as evidenced by reports of user dissatisfaction with non-biological feedback loops. Peer-reviewed analyses emphasize the need for longitudinal to validate claims of net benefit over deviation-induced pathologies.

Fairness and Competition Issues (e.g., Sports)

The case of highlighted prosthetic use in able-bodied competitions, where the International Association of Athletics Federations (IAAF, now ) initially banned him in 2007 from events after a biomechanical study by Peter Bruggemann found that his carbon-fiber Cheetah Flex-Foot blades returned nearly three times the positive energy of ankle joints during maximum sprinting, with an energy loss of approximately 9% compared to greater dissipation in biological limbs. This return, absent in running where muscles perform negative work to control motion, suggested a potential metabolic advantage, enabling sustained lower energy costs over race distances. The overturned the ban in 2008, ruling that the evidence did not conclusively demonstrate a net advantage across an entire 400-meter race, as Pistorius exhibited higher oxygen consumption at certain speeds; he subsequently competed in the 2012 London Olympics, reaching the 400-meter semifinals without advancing to finals. Biomechanical analyses underscore causal differences: prostheses like the Flex-Foot eliminate biological mechanisms and weight penalties from unused muscle , potentially reducing overall expenditure by up to 25% in sustained efforts, though sprint-specific top speeds may not exceed biological limits due to altered ground reaction forces and stride . Empirical modeling indicates selection biases in fairness metrics, as prosthetic designs optimize for and return—often exceeding 90% efficiency—bypassing human physiological constraints like muscle , which prioritizes control over pure . Recent reviews confirm that running-specific prostheses (RSPs) alter limb and distribution, conferring advantages in metabolic economy for longer distances, challenging assumptions of equivalence in mixed competitions. In , classifications address fairness by grouping athletes by impairment type, location, and severity—such as T63 for above-knee amputees using prostheses with knee joints—aiming to minimize performance disparities within classes while permitting technological aids. However, advancing prosthetic technology, including variable stiffness and lightweight composites, necessitates ongoing reevaluation to counteract unintended advantages, as evidenced by debates over whether such devices preserve the sport's emphasis on human or introduce non-biological enhancements that skew causal performance pathways. Proponents of prosthetic inclusion argue for equity through technological normalization, positing that denying access perpetuates ableism and that empirical outcomes, like Pistorius's times comparable to elite standards without dominance, affirm competitiveness without undue edge. Critics, drawing from first-principles of athletic purity, contend that prostheses fundamentally decouple performance from innate human biomechanics, creating unverifiable advantages in energy efficiency and durability that undermine the causal integrity of natural selection in competition, as biological limbs inherently balance propulsion with stability costs not replicable equivalently. Governing bodies thus enforce regulations, such as World Athletics' 2020 ruling against above-ankle prostheses in able-bodied events, prioritizing empirical thresholds over subjective equity claims.

Resource Allocation and Equity Concerns

Globally, the estimates that 35-40 million individuals require prosthetic and orthotic services due to limb loss or impairment, yet fewer than 10% have access to appropriate assistive devices, with even lower rates for advanced prosthetics in low-income regions. In developing countries, where the majority of amputations occur, access hovers around 5% for basic prosthetics, exacerbating disparities driven by economic constraints and limited . These gaps highlight causal factors such as and inadequate healthcare systems, which prioritize survival over rehabilitation, leaving millions dependent on rudimentary mobility aids or none at all. In the United States, private insurance frequently denies coverage for advanced prosthetics, citing lack of medical necessity or experimental status, despite federal guidelines under Medicare and robust coverage through the Department of Veterans Affairs for eligible recipients. Approximately half of states have enacted prosthetic parity laws to align private coverage with original Medicare standards, yet denials persist, particularly for microprocessor-controlled limbs costing $30,000 to $60,000. This creates inequities between insured civilians and veterans, where VA provision enables higher functional outcomes without similar bureaucratic hurdles. Ethical debates center on resource rationing through cost-benefit analyses, weighing individual benefits against societal opportunity costs for devices often exceeding $50,000 per limb. Proponents of utilitarian allocation argue for prioritizing high-return interventions based on quality-adjusted life years (QALYs), while critics contend this undervalues restoration of basic mobility for marginalized groups, potentially perpetuating cycles of dependency. Empirical indicate prosthetics yield positive returns on , with early fitting reducing long-term healthcare utilization and enabling workforce reentry, though subsidies risk market distortions by inflating prices without addressing root inefficiencies. Balancing universal access aspirations against fiscal realism remains contentious, as unchecked welfare expansions may erode incentives for and personal responsibility in rehabilitation.

Economic Accessibility and Global Implementation

Cost Structures of Advanced vs Basic Prosthetics

Basic prosthetic limbs, relying on mechanical components and body-powered mechanisms such as cables and hooks, generally range from $3,000 to $10,000 depending on the level and materials like basic plastics or aluminum. In contrast, advanced prosthetics incorporating myoelectric controls—detecting electromyographic signals from residual muscles—or knees for adaptive , command prices of $20,000 to $100,000 or more, driven by integrated electronics, sensors, and programmable algorithms. Emerging brain-computer interface (BCI)-enabled systems, still largely experimental as of 2025, extend costs beyond this range due to neurosurgical implantation and neural hardware, though widespread pricing data remains limited. The disparity arises from causal factors including raw material sophistication—carbon fiber composites and in advanced models versus entry-level alloys—and the amortization of expenditures, where high-tech features necessitate FDA approvals and small-batch that inflates per-unit pricing. Customization for user , including socket fitting and alignment, adds 10-20% to totals for both categories but scales higher in advanced units due to iterative software tuning. Maintenance compounds this: basic prosthetics incur lower repair costs from simpler mechanics, while advanced ones demand battery replacements and updates, often totaling 20-30% of initial outlay annually.
Prosthetic TypeCost Range (USD)Primary Functionality DriversPrice Multiplier Relative to Basic
Basic Mechanical$3,000–$10,000Body-powered leverage; passive stability1x
Myoelectric/Microprocessor$20,000–$100,000Signal-responsive actuation; adaptive response to 4–10x
Empirical assessments reveal advanced prosthetics deliver roughly twofold enhancements in functional metrics—such as grip precision or stumble recovery—over basic models, yet at fivefold or greater expense, with knees reducing fall risks by up to 60% in trials but not proportionally offsetting acquisition costs. Market-driven pricing prevails, with manufacturers recouping R&D via premiums rather than volume sales, supplemented by or charitable programs for select users, though insurance reimbursement introduces variability: Medicare funds 80% of approved devices, while private plans frequently contest advanced coverage as insufficiently "medically necessary," leading to denials in up to 45 states lacking mandates. This structure underscores value trade-offs, where basic options suffice for mobility restoration at lower barriers, while advanced yields marginal gains for specialized needs like fine manipulation, contingent on payer policies.

Low-Cost Innovations and Open-Source Models

The e-NABLE initiative, launched in , pioneered open-source 3D-printed prosthetic hands designed primarily for children with deficiencies, enabling production at costs of $25 to $50 using accessible desktop printers and volunteer networks. These devices leverage community-driven design files shared freely online, allowing global fabrication without proprietary barriers, and have been distributed to thousands in low-resource areas where traditional prosthetics exceed $10,000. Empirical assessments indicate functional utility for basic grasping tasks, though long-term durability varies based on print quality and user maintenance. In parallel, innovations using locally sourced materials like laminates for lower limb prosthetics have emerged in and , yielding feet and sockets that are sustainable and producible at fractions of commercial costs—often under $100—while maintaining comparable mechanical performance to imported alternatives in static load tests. Such approaches emphasize empirical scalability, with field trials in developing countries demonstrating reduced dependency on imported components and faster turnaround via on-site workshops, achieving up to 80% cost savings relative to polypropylene-based standards from organizations like the International Committee of the Red Cross. Open-source models accelerate iteration through collaborative refinements, fostering adaptability to diverse anatomies and enabling local technicians to customize fits without advanced engineering expertise, which has proven causal to higher adoption rates in resource-poor settings. However, quality variance arises from inconsistent printer calibration, filament standards, and assembler skill, potentially compromising structural integrity and elevating risks of socket pressure sores or secondary infections if hygiene protocols lapse during fabrication or use. For pediatric applications, these low-cost designs incorporate modular elements and adjustable components to accommodate rapid growth, with transitional 3D-printed hands remade every 6-12 months at minimal expense, supporting and development as evidenced by case studies of improved daily function post-fitting. Local fabrication successes, such as mobile 3D printing units in , have scaled to equip hundreds of users annually, correlating with enhanced mobility metrics in community-based evaluations over traditional wait-listed imports.

Policy Barriers and Market-Driven Solutions

Regulatory barriers to prosthetic innovation primarily stem from stringent premarket approval requirements imposed by agencies like the U.S. (FDA), particularly for Class III devices such as advanced neural prosthetics or brain-computer interfaces (BCIs) that restore motor function. The Premarket Approval (PMA) pathway for these high-risk devices mandates extensive clinical data and safety reviews, with statutory review periods of at least 180 days but often extending to 243 days on average for the formal decision, excluding preparatory trials that can span 3-7 years total. These timelines disproportionately burden startups lacking resources for prolonged compliance, stifling entry and innovation compared to private-sector development speeds where prototypes can iterate in months. Empirical evidence of delays is evident in BCI rollout, where Neuralink's initial human application faced FDA rejection in early 2023 due to safety concerns like battery risks and wire migration, postponing approval until May 2023 despite prior success. Such absolutist safety standards, prioritizing zero-risk over , contrast with historical medical advancements where tolerable risks enabled progress, as seen in earlier cardiac implants approved amid imperfect data. This regulatory caution, while rooted in post-1976 amendments to prevent harms like the , empirically correlates with slower diffusion of life-enhancing technologies, with FDA rejecting about one-third of initial device requests. Market-driven solutions mitigate these barriers through mechanisms like FDA's program, allowing compassionate use of investigational devices for patients with serious conditions outside formal trials, often approved in 30 days for single-patient cases. In the 2020s, this pathway facilitated earlier access to neural implants, bypassing full PMA delays while collecting real-world data to inform approvals, as with Precision Neuroscience's 2025 clearance for short-term BCI implantation. Competition in less-regulated segments, such as 3D-printed prosthetics, has further lowered costs by enabling scalable production without exhaustive R&D mandates, reducing prices from traditional $10,000+ levels through and reduced . Deregulatory precedents, including streamlined reviews under the , demonstrate that easing mandates spurs rivalry, cuts prices via economies of scale, and enhances safety through iterative post-market surveillance rather than preemptive perfectionism. Free-market dynamics thus favor risk-tolerant users benefiting from rapid advancements, outweighing rare failures when weighed against inaction's certain costs in unmet needs.

Future Trajectories

Emerging Technologies and R&D Frontiers

In 2024, researchers at MIT developed a surgical technique called amplified peripheral regeneration, which reroutes remaining to muscle grafts in the residual limb, seven amputees to control prosthetic legs with enhanced neural feedback and achieve more natural patterns, including obstacle navigation, as demonstrated in clinical evaluations. This approach builds on peripheral neural interfaces, with ongoing trials in 2025 exploring combined with neural implants for upper-limb prosthetics, where early case reports show improved signal stability but remain limited to small cohorts due to implantation risks. Brain-computer interfaces (BCIs) adjacent to systems like are advancing prosthetic sensory restoration; in January 2025, trials used targeted to deliver timed tactile feedback, allowing users to distinguish textures and pressures in prosthetic hands with 75-90% accuracy in controlled tests. Similarly, a September 2025 at is evaluating sensory prostheses for upper-limb amputees, incorporating implanted electrodes to transmit touch data directly to nerves, with initial phases documenting baseline prosthetic use before integration. AI-integrated haptics are emerging in prototypes tested through 2025, with systems using to process sensor data from e-skin and , enabling adaptive feedback that mimics touch sensation; for instance, AI algorithms in lower-limb devices interpret pressure and vibration to adjust in real-time during pilot studies. These rely on declining computational costs— extensions have reduced AI training expenses by over 100-fold since 2010—facilitating edge processing in wearables, though past overpromises in neural prosthetics, such as unfulfilled 2010s targets for full sensory restoration, underscore the need for validated trial data over hype. Regenerative interfaces combining hybrids with entered preclinical pipelines in 2024, including regenerative peripheral nerve interfaces (RPNIs) that graft muscles to amplify nerve signals for prosthetic control, showing in animal models a 2-3 fold increase in regrowth for hand applications. Biohybrid systems, merging implantable with cell transplants, aim for tissue-device integration, with 2024 studies demonstrating sustained electrical conduction . 3D bioprinting scaffolds for prosthetic augmentation focus on and hybrids, with 2024 advances in hydrogel-based prints incorporating stem cells to form vascularized scaffolds that support prosthetic anchoring; mechanical testing revealed compressive strengths matching native at 10-20 MPa, advancing toward hybrid limb trials. These scaffolds enable regenerative , reducing rejection in preclinical models by 30-50% compared to traditional implants.

Systemic Challenges to Adoption

High abandonment rates of prosthetic devices represent a primary barrier to sustained adoption, with studies indicating that 20-30% of lower-limb prosthesis users discontinue use within the first year due to factors including device complexity, discomfort, and pain during operation. For upper-limb prostheses, abandonment reaches 44% overall, escalating to 50-60% in proximal amputations, often attributed to inadequate restoration of function relative to effort required. These rates stem causally from mismatches between device ergonomics and user physiology, where over 50% of users report pain and 57% dissatisfaction with comfort, compounded by the cognitive load of relearning movements without natural proprioception. Training deficiencies exacerbate non-use, as insufficient initial prosthetic rehabilitation correlates with lower satisfaction and higher rejection; for instance, predictors of abandonment include higher levels and reliance on alternative mobility aids, underscoring the need for specialized prosthetist skills in precise fitting and alignment to mitigate deviations and irritation. Ill-fitting prostheses, arising from skill gaps in clinical assessment and adjustment, lead to skin breakdown, socket pressure sores, and reduced mobility, with prosthetists citing service disparities and practice limitations as recurrent issues in achieving optimal outcomes. While technological advancements like sensor-integrated sockets offer potential remedies, user demands rigorous, individualized protocols emphasizing balance and weight-shifting, placing partial responsibility on patients to engage consistently beyond device provision. Supply chain vulnerabilities further hinder adoption, particularly through shortages of critical materials like , which has become scarcer and costlier for orthopedic device manufacturers since 2022 disruptions, delaying production and increasing prices by over 90% in some periods. These geopolitical and dependencies amplify global inequities, as developing regions face prolonged wait times and limited access to components, indirectly reinforced by protections on advanced designs that restrict low-cost replication despite open-source alternatives emerging for basic models. Infrastructure deficits, including sparse prosthetist training facilities, perpetuate cycles of poor fitting and abandonment in low-resource settings, where empirical data show non-use rates mirroring or exceeding those in high-income contexts due to unaddressed causal factors like inconsistent supply and expertise gaps.

Long-Term Societal and Transhumanist Implications

Prosthetics, initially developed for restoration, increasingly enable augmentation that blurs the line between and enhancement, positioning them as precursors to transhumanist goals of transcending biological limits. Proponents argue that by 2050, advanced neural interfaces and biomechanical integrations could achieve full-body prosthetics with , endurance, or sensory acuity, marking a deliberate evolutionary leap driven by human agency rather than . This vision aligns with transhumanist principles of radical and capability expansion, where prosthetic technologies evolve into ubiquitous upgrades, potentially redefining human identity as a hybrid of organic and synthetic elements. Demographic pressures amplify these trajectories, with the prevalence of limb loss projected to double to 3.6 million individuals by 2050, largely attributable to complications and population aging, while global cases—often leading to amputations—could reach 360 million. Such statistics underscore a causal imperative for scalable enhancements, as untreated metabolic conditions erode natural resilience and impose mounting societal burdens on healthcare systems. Transhumanists contend that widespread adoption of augmentative prosthetics could counteract these trends by fostering individual and , shifting reliance from passive welfare models to self-directed technological adaptation. Critics, however, warn that unequal access to enhancements will entrench class divides, creating a bifurcated of enhanced elites and unaugmented underclasses, thereby exacerbating rather than alleviating inequality. Naturalist perspectives further caution that prosthetic augmentation undermines the intrinsic value of embodiment, eroding forged through acceptance of natural frailties and risking a loss of humility toward biological givens; as philosopher argues, such interventions express a drive for mastery that closes individuals to the unbidden aspects of the human condition, potentially diminishing moral and existential depth. on early adopters shows mixed outcomes, with some gaining independence but others facing adaptation failures tied to pre-existing traits like , suggesting enhancements may not universally build resilience but instead foster dependency on iterative upgrades. Counterarguments grounded in historical technology diffusion posit that initial disparities in prosthetic access will diminish as production scales, akin to how democratized capabilities once deemed elite, ultimately empowering broader over state-mediated aid. Yet, first-principles evaluation reveals no inherent guarantee against stratified outcomes, as enhancements could amplify causal feedback loops where the augmented accrue compounding advantages in labor markets and , challenging notions of equal without rigorous policy interventions. This debate encapsulates transhumanism's promise of liberation from frailty against risks of , demanding scrutiny of whether prosthetic futures prioritize empirical human flourishing or ideological transcendence.

References

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