Lower-Extremity Prosthetics

More than 100 different prosthetic ankle-foot and knee designs are currently available. The choice of the most appropriate design may depend on the patient’s underlying activity level. For example, the requirements of a prosthetic knee in an elderly, largely homebound individual will differ from those of a younger, active person. Key elements of a prosthetic knee design involve providing stability during both the stance and swing phase of the gait. Prosthetic knees vary in their ability to alter the cadence of the gait, or the ability to walk on rough or uneven surfaces. In contrast to more simple prostheses, which are designed to function optimally at one walking cadence, fluid and hydraulic-controlled devices are designed to allow amputees to vary their walking speed by matching the movement of the shin portion of the prosthesis to the movement of the upper leg. For example, the rate at which the knee flexes after “toe-off” and then extends before heel strike depends in part on the mechanical characteristics of the prosthetic knee joint. If the resistance to flexion and extension of the joint does not vary with gait speed, the prosthetic knee extends too quickly or too slowly relative to the heel strike if the cadence is altered. When properly controlled, hydraulic or pneumatic swing-phase controls allow the prosthetist to set a pace adjusted to the individual amputee, from very slow to a race-walking pace. Hydraulic prostheses are heavier than other options and require gait training; for these reasons, these prostheses are prescribed for athletic or fit individuals. Other design features include multiple centers of rotation, referred to as “polycentric knees.” The mechanical complexity of these devices allows engineers to optimize selected stance and swing-phase features.

Regulatory Status

According to the manufacturers, microprocessor-controlled prostheses are considered a class I device by the FDA and are exempt from 510(k) requirements. This classification does not require submission of clinical data regarding efficacy but only notification of FDA prior to marketing. FDA product codes: ISW, KFX.

Related Policies

• Neuromuscular Electrical Stimulation (NMES) and Functional Electrical Stimulation (FES) (Policy #014 in the DME Section)
• Myoelectric Prosthetic and Orthotic Components for the Upper Limb (Policy #034 in the DME Section)

I. A microprocessor-controlled knee (L5856 - L5858) is considered medically necessary in individuals with transfemoral amputation who meet all of the following general requirements (Patient selection guidelines are discussed under the INFORMATIONAL NOTE Section below):

A. Member must meet at least one of the following:
1. Demonstrated need for long distance ambulation at variable rates, OR

(NOTE: Use of the limb in the home or for basic community ambulation is not sufficient to justify provision of the computerized limb over standard limb applications.)

2. Demonstrated patient need for regular ambulation on uneven terrain or for regular use on stairs; AND

(NOTE: Use of the limb for limited stair climbing in the home or employment environment is not sufficient evidence for prescription of this device over standard prosthetic application.)

B. Physical ability, including adequate cardiovascular and pulmonary reserve, for ambulation at faster than normal walking speed; AND

C. Adequate cognitive ability to master use and care requirements for the technology.

A. has a stable wound

B. has the ability to fit socket

C. immediate post-operative fit is possible

D. must have the potential to return to active lifestyle

• Medicare Level K 0 — no ability or potential to ambulate or transfer.
• Medicare Level K 1 — limited ability to transfer or ambulate on level ground at fixed cadence.
• Medicare Level K 2 — limited community ambulator that does not have the cardiovascular reserve, strength, and balance to improved stability in stance to permit increased independence, less risk of falls, and potential to advance to a less-restrictive walking device.
• When the primary benefit is to allow the patient to perform leisure or recreational activities.
• Any condition which prevents socket fitting, such as a complicated wound or intractable pain which precludes socket wear.
• Inability to tolerate the weight of the prosthesis.
• Inability to utilize swing and stance features of the knee unit.
• Poor balance or ataxia that limits ambulation.
• Significant hip flexion contracture (over 20 degrees).
• Significant deformity of remaining limb that would impair ability to stride.
• Limited cardiovascular and/or pulmonary reserve or profound weakness.
• Limited cognitive ability to understand gait sequencing or care requirements.
• Long distance or competitive running.
• Falls outside of recommended weight or height guidelines of manufacturer.
• Specific environmental factors—such as excessive moisture or dust, or inability to charge the prosthesis.
• Extremely rural conditions where maintenance ability is limited.

A. For insured benefit plans that provide benefits for prosthetic devices and for ASO/ASC/Self-Insured/Self-Funded Groups which opted to adopt the New Jersey State Mandate on Orthotic and Prosthetic Appliances:

A powered knee and its corresponding accessories are automatically eligible for coverage if the following are met:
1. the powered knee is determined to be medically necessary by the member's physician, and
2. the powered knee is obtained from a licensed prosthetist or a certified pedorthist

B. For ASO/ASC/Self-Insured/Self-Funded Groups which opted not to adopt the New Jersey State Mandate on Orthotic and Prosthetic Appliances:

A powered knee and its corresponding accessories are considered investigational.

[INFORMATIONAL NOTE: The New Jersey State Mandate on Orthotic and Prosthetic Appliances (N.J.S.A. 17:48E-35.30, effective April 15, 2008) requires insured health benefit plans that provide benefits for orthotic and prosthetic devices to provide coverage for expenses incurred in obtaining orthotic and prosthetic appliances from any licensed orthotist, prosthetist, or any certified pedorthist if determined to be medically necessary by the covered person's physician. Prosthetics that are not surgically implanted are automatically eligible for coverage under the mandate if determined to be medically necessary by the covered person's physician.

ASO/ASC/Self-Insured/Self-Funded Groups are exempt from these State mandated requirements but may choose to include these benefits at their discretion. For those self-insured accounts which opted not adopt the mandate, a powered knee is considered investigational.]

A. For insured benefit plans that provide benefits for prosthetic devices and for ASO/ASC/Self-Insured/Self-Funded Groups which opted to adopt the New Jersey State Mandate on Orthotic and Prosthetic Appliances:

A microprocessor-controlled or powered foot and its corresponding accessories are automatically eligible for coverage if the following are met:
1. the microprocessor-controlled or powered foot is determined to be medically necessary by the member's physician, and
2. the powered foot is obtained from a licensed prosthetist or a certified pedorthist

B. For ASO/ASC/Self-Insured/Self-Funded Groups which opted not to adopt the New Jersey State Mandate on Orthotic and Prosthetic Appliances:

A microprocessor-controlled or powered foot and its corresponding accessories are considered investigational.

[INFORMATIONAL NOTE: The New Jersey State Mandate on Orthotic and Prosthetic Appliances (N.J.S.A. 17:48E-35.30, effective April 15, 2008) requires insured health benefit plans that provide benefits for orthotic and prosthetic devices to provide coverage for expenses incurred in obtaining orthotic and prosthetic appliances from any licensed orthotist, prosthetist, or any certified pedorthist if determined to be medically necessary by the covered person's physician. Please note that prosthetics that are not surgically implanted are automatically eligible for coverage under the mandate if determined to be medically necessary by the covered person's physician.

ASO/ASC/Self-Insured/Self-Funded Groups are exempt from these State mandated requirements but may choose to include these benefits at their discretion. For those self-insured accounts which opted not adopt the mandate, a microprocessor-controlled or powered foot is considered investigational.]

VII. Replacement of a prosthesis or prosthetic component is covered if the treating physician orders a replacement device or part because of any of the following:

1. A change in the physiological condition of the member; or
2. Irreparable wear of the device, or part of the device; or
3. The condition of the device, or part of the device, requires repairs and the cost of such repairs would be more than 60% of the cost of a replacement device, or of the part being replaced.

Replacement of a prosthesis or prosthetic components required because of loss or irreparable damage may be reimbursed without a physician's order when it is determined that the prosthesis as originally ordered still fills the member's medical needs.

· Will reach or maintain a defined functional state within a reasonable period of time;
· Is motivated to ambulate and
· Meets LCD L33787 and A52496 policy criteria.

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

Policy Guidelines: (Information to guide medical necessity determination based on the criteria contained within the policy statements above.)

Amputees should be evaluated by an independent, qualified professional to determine the most appropriate prosthetic components and control mechanism. A trial period may be indicated to evaluate the tolerability and efficacy of the prosthesis in a real-life setting. Decisions about the potential benefits of microprocessor knees involve multiple factors including activity levels and the patient's physical and cognitive ability. A patient's need for daily ambulation of at least 400 continuous yards, daily and frequent ambulation at variable cadence or on uneven terrain (eg, gravel, grass, curbs), and daily and frequent use of ramps and/or stairs (especially stair descent) should be considered as part of the decision. Typically, daily and frequent need of two or more of these activities would be needed to show benefit.

PATIENT SELECTION AND IDENTIFICATION
For patients in whom the potential benefits of the microprocessor knees are uncertain, patients may first be fitted with a standard prosthesis to determine their level of function with the standard device.

The following are guidelines from the Veterans Health Administration Prosthetic Clinical Management Program Clinical Practice Recommendations for Microprocessor Knees (Berry, 2000).

A. Contraindications for the use of the microprocessor knee should include the following:
· Any condition that prevents socket fitting, such as a complicated wound or intractable pain which precludes socket wear.
· Inability to tolerate the weight of the prosthesis.
· Medicare level K0—no ability or potential to ambulate or transfer.
· Medicare level K1—limited ability to transfer or ambulate on level ground at fixed cadence.
· Medicare level K2—limited community ambulator who does not have the cardiovascular reserve, strength, and balance to improve stability in stance to permit increased independence, less risk of falls, and potential to advance to a less restrictive walking device.
· Inability to use swing and stance features of the knee unit.
· Poor balance or ataxia that limits ambulation.
· Significant hip flexion contracture (>20).
· Significant deformity of remaining limb that would impair the ability to stride.
· Limited cardiovascular and/or pulmonary reserve or profound weakness.
· Limited cognitive ability to understand gait sequencing or care requirements.
· Long distance or competitive running.
· Falls outside of recommended weight or height guidelines of the manufacturer.
· Specific environmental factors—such as excessive moisture or dust, or inability to charge the prosthesis.
· Extremely rural conditions where maintenance ability is limited.

B. Indications for the use of the microprocessor knee should include the following:
· Adequate cardiovascular and pulmonary reserve to ambulate at variable cadence.
· Adequate strength and balance in stride to activate the knee unit.
· Should not exceed the weight or height restrictions of the device.
· Adequate cognitive ability to master technology and gait requirements of the device.
· Hemi-pelvectomy through knee-disarticulation level of amputation, including bilateral; lower extremity amputees are candidates if they meet functional criteria as listed.
· The patient is an active walker and requires a device that reduces energy consumption to permit longer distances with less fatigue.
· Daily activities or job tasks that do not permit full focus of concentration on knee control and stability—such as uneven terrain, ramps, curbs, stairs, repetitive lifting, and/or carrying.
· Medicare level K2—limited community ambulator, but only if improved stability in stance permits increased independence, less risk of falls, and potential to advance to a less restrictive walking device, and the patient has cardiovascular reserve, strength, and balance to use the prosthesis. The microprocessor enables fine-tuning and adjustment of the hydraulic mechanism to accommodate the unique motor skills and demands of the functional level K2 ambulator.
· Medicare level K3—unlimited community ambulator.
· Medicare level K4—active adult, athlete who needs to function as a K 3 level in daily activities.
· Potential to lessen back pain by providing more secure stance control, using less muscle control to keep the knee stable.
· Potential to unload and decrease stress on remaining limb.
· Potential to return to an active lifestyle.

C. Physical and Functional Fitting Criteria for New Amputees:
· New amputees may be considered if they meet certain criteria as outlined above.
· Premorbid and current functional assessment important determinant.
· Requires stable wound and ability to fit the socket.
· Immediate postoperative fit is possible.
· Must have potential to return to an active lifestyle.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function¾including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Powered Prostheses

Clinical Context and Therapy Purpose

The purpose of powered prostheses in patients who have transfemoral or tibial amputationis to improve activity and fucntion.

The question addressed in this policy is: doespowered prostheses improve the net health outcome in individuals with lower-extremity amputations?

The following PICOTS were used to select literature to inform this review.

Patients

The relevant population(s) of interest are people with transfemoral or tibial amputation.

Interventions

The therapy being considered is powered prostheses.

Microprocessor-Controlled Prosthetic Knees

Microprocessor-controlled prosthetic knees have been developed, including the Intelligent Prosthesis (Blatchford); the Adaptive (Endolite); the Rheo Knee® (Össur); the C-Leg®, Genium™ Bionic Prosthetic System, and the X2 and X3 prostheses (Otto Bock Orthopedic Industry); and Seattle Power Knees (3 models include Single Axis, 4-bar, and Fusion, from Seattle Systems). These devices are equipped with a sensor that detects when the knee is in full extension and adjusts the swing phase automatically, permitting a more natural walking pattern of varying speeds. The prosthetist can specify several different optimal adjustments that the computer later selects and applies according to the pace of ambulation. Also, these devices (except the Intelligent Prosthesis) use microprocessor control in both the swing and stance phases of gait. (The C-Leg Compact provides only stance control.) By improving stance control, such devices may provide increased safety, stability, and function. For example, the sensors are designed to recognize a stumble and stiffen the knee, thus avoiding a fall. Other potential benefits of microprocessor-controlled knee prostheses are improved ability to navigate stairs, slopes, and uneven terrain and reduction in energy expenditure and concentration required for ambulation. In 1999, the C-Leg was cleared for marketing by the Food and Drug Administration (FDA) through the 510(k) process (K991590). Next-generation devices such as the Genium Bionic Prosthetic system and the X2 and X3 prostheses use additional environmental input (eg, gyroscope and accelerometer) and more sophisticated processing that is intended to create more natural movement. One improvement in function is step-over-step stair and ramp ascent. They also allow the user to walk and run forward and backward. The X3 is a more rugged version of the X2 that can be used in water, sand, and mud. The X2 and X3 were developed by Otto Bock as part of the Military Amputee Research Program.

Powered Knee Prostheses

The Power Knee™ (Össur), which is designed to replace muscle activity of the quadriceps, uses artificial proprioception with sensors similar to the Proprio Foot to anticipate and respond with the appropriate movement required for the next step.

Microprocessor-Controlled Ankle-Foot Prostheses

Microprocessor-controlled ankle-foot prostheses are being developed for transtibial amputees. These include the Proprio Foot® (Össur), the iPED (developed by Martin Bionics and licensed to College Park Industries), and the Elan Foot (Endolite). With sensors in the feet that determine the direction and speed of the foot’s movement, a microprocessor controls the flexion angle of the ankle, allowing the foot to lift during the swing phase and potentially adjust to changes in force, speed, and terrain during the step phase. This technology is designed to make ambulation more efficient and prevent falls in patients ranging from the young, active amputee to the elderly, diabetic patient. The Proprio Foot® and Elan Foot are microprocessor-controlled foot prostheses that are commercially available at this time and are considered class I devices that are exempt from 510(k) marketing clearance. Information on the Össur website indicates the use of the Proprio Foot® for low- to moderate-impact for transtibial amputees who are classified as level K3 (ie, community ambulatory, with the ability or potential for ambulation with variable cadence).

Powered Ankle-Foot Prostheses

In development are lower-limb prostheses that also replace muscle activity to bend and straighten the prosthetic joint. For example, the PowerFoot BiOM® (developed at the Massachusetts Institute of Technology and licensed to iWalk) is a myoelectric prosthesis for transtibial amputees that uses muscle activity from the remaining limb for the control of ankle movement. This prosthesis is designed to propel the foot forward as it pushes off the ground during the gait cycle, which in addition to improving efficiency, has the potential to reduce hip and back problems arising from an unnatural gait with use of a passive prosthesis. This technology is limited by the size and the weight required for a motor and batteries in the prosthesis.

Comparators

The relevant comparator is prosthesis with a conventional knee or ankle/foot.

Outcomes

Relevant outcomes for microprocessor-controlled lower-limb prostheses may include the patient’s perceptions of subjective improvement attributable to the prosthesis and level of activity or function. Also, the energy costs of walking or gait efficiency may be a more objective measure of the clinical benefit of the microprocessor-controlled prosthesis.

Microprocessor-Controlled Knee

The Veterans Administration Technology Assessment Program (2000) issued a report on computerized lower-limb prosthesis.^1, This report offered the following observations and conclusions:

• Energy requirements of ambulation (vs requirements with conventional prostheses) are decreased at walking speeds slower or faster than the amputee’s customary speed but do not differ significantly at customary speeds.
• Results on the potentially improved ability to negotiate uneven terrain, stairs, or inclines are mixed. Such benefits, however, could be particularly important to meeting existing deficits in the reintegration of amputees to normal living, particularly those related to decreased recreational opportunities.
• Users’ perceptions of the microprocessor-controlled prosthesis are favorable. Where such decisions are recorded or reported, most study participants choose not to return to their conventional prosthesis or to keep these only as a back-up to acute problems with the computerized one.
• Users’ perceptions may be particularly important for evaluating a lower-limb prosthesis, given the magnitude of the loss involved, along with the associated difficulty of designing and collecting objective measures of recovery or rehabilitation. However resilient the human organism or psyche, loss of a limb is unlikely to be fully compensated. A difference between prostheses sufficient to be perceived as distinctly positive to the amputee may represent the difference between coping and a level of function recognizably closer to the preamputation level.

About half of the studies first tested participants with their own non-microprocessor prosthesis followed by an acclimation period and testing with the microprocessor-controlled knee (see Table 1). The other studies used an alternating or randomized order, with more than one test session for each type of prosthesis. Most studies compared performance in laboratory activities and about half also included a period of home use.

Table 1. Within-Subject Study Characteristics of the Microprocessor Knee

Study	Study Location	Country	N	Participants	MPK	NMPK	Home Monitoring
K2 ambulators
Theevenet al (2011, 2012)2,3,	Activity at home and lab-simulated ADLs	Netherlands	28	Functional level K2	C-Leg and C-Leg compact 1-wk acclimation	Own NMPK	1 wk for each prosthesis
Burnfield et al (2012)4,	Level and ramp walking	U.S.	10	Functional level K2	C-Leg compact 3-mo acclimation	Own NMPK
K2 to K3 ambulators
VA (2006)5,6,7,	Lab and home	U.S.	8	Functional level K2 to K3	C-Leg	Hydraulic	1wk
Hafner and Smith (2009)8,	A-B-A-(A or B) design in lab and city sidewalk	U.S.	·   8 K2 ·   9 K3	Functional level K2 to K3	Retest in lab with preferred prosthesis	Retest in lab with preferred prosthesis	Prior 4 wk from 4-, 8-, and 12-mo tests
Highsmith et al (2013)9,	Ramp		21	Independent community ambulator	C-leg with 3-mo acclimation	Own NMPK
Howard et al (2018)10,	4-wk laboratory sessions for each phase (A-B-A or B-A-B)	U.S.	·   1 K2 ·   6 K3	Functional level K2 or K3	Rheo Knee	Own NMPK	PROs for 3 wk prior touse
Hafner et al (2007)11,	A-B-A-B design in lab and city sidewalk	U.S.	17	Proficient community ambulator		Own mechanical
Kaufman et al (2018)12,	Free living environment	US	50 48 K2	Functional level K2 or K3	One of 4 MPK devices	Own NMPK	Functional measures and PROs 10 weeks
K3 to K4 ambulators
Kaufman et al (2007, 2008)13,14,	Lab and home	U.S.	15	Functional level K3 or K4	MPK acclimation of 10-39 wk	Own NMPK	10 d
Johansson (2005)15,	Laboratory and 0.25-mile indoor track	U.S.	8	Functional level K3 or K4	10-h acclimation if not owned	10-h acclimation if not owned

ADLs: activities of daily living; MPK: microprocessor knee; NMPK non-microprocessor knee; PROs: patient-reported outcomes; VA: Veterans Administration.

Results of these studies are described in Table 2 and summarized below:

·         In K2 ambulators, the C-Leg and C-Leg compact improved performance on simulated activities of daily living that required balance, for walking on level ground and ramps, and led to a faster time to stand up from a seated position and move forward (Timed Up & Go test). In the single study that measured activity levels at home, use of a microprocessor-controlled knee did not increase objectively measured activity.

·         In studies that included K2 to K3 ambulators, use of a microprocessor-controlled knee increased balance, mobility, speed, and distance compared with performance using the participant’s prosthesis. In studies that included independent or proficient community ambulators, the greatest benefit was for the descent of stairs and hills. Normal walking speed was not increased. In a study that primarily included K2 ambulators there was a reduction in falls demonstrated by the change from baseline while using MPK and an increase in falls with reversion to NMPK.

·         In studies that included K3 to K4 ambulators, use of a prosthesis with a microprocessor-controlled knee resulted in a more natural gait, and an increase in activity at home. Participants voiced a strong preference for the microprocessor knee.

·         Irrespective of the MFL from K2 to K4, all studies reported that participants preferred the C-Leg or C-Leg compact over their non-microprocessor prosthesis.

Table 2. Outcomes With Microprocessor Knee Prosthesis vs a Non-Microprocessor Knee

Study	Performance	Gait Efficiency	Preference (Self-Report or PEQ)	Activity at Home
K2 ambulators
Theevenet al (2011, 2012)2,3,	Improved simulated ADLs for activities requiring balance		·   Subjective benefit on PEQ ·   No preference for C-leg over C-leg compact	No difference in objectively measured activity level
Burnfield et al (2012)4,	Improved walking on level ground, ramps, and faster TUG (17.7 s vs 24.5 s)		·   PEQ ·   All wanted to keep the C-Leg compact
K2 to K3 ambulators
VA (2006)5,6,7,		Marginally improved	7 of 8 participants preferred the MPK	No difference
Hafner and Smith (2009)8,	Improved mobility and speed			Decrease in self-reported stumbles and falls
Highsmith et al (2013)9,	Improved hill descent time (6.0 s vs 7.7 s) and HAI
Howard et al. (2018)10,	Improved 6MWT, BBS, and AMP, but inconsistent for normal walking speed and L test	Improved Physiological Cost Index	·   Preference for MPK in 6 of 7 participants ·   PEQ superior in 5 of 7
Hafner et al (2007)11,	Improved for descent of stairs and hills only		Subjective improvement with MPK
Kaufman et al (2018)12,	Reduction in falls			Subjective improvement in PEQ satisfaction with MPK
K3 to K4 ambulators
Kaufman et al (2007, 2008)13,14,	More natural gait	No significant difference	Preferred MPK	Increased
Johansson (2005)15,	More natural gait and decrease in hip work	Oxygen consumption reduced for Rheo but not C-Leg	Preferred MPK

ADL: activity of daily living; AMP: amputee mobility predictor; BBS: Berg Balance Scale; HAI: Hill Assessment Index; MPK: microprocessor knee; NMPK non-microprocessor knee; PEQ: Prosthesis Evaluation Questionnaire; 6MWT: 6-minute walk test; TUG: Timed Up & Go; VA: Veterans Administration.

Section Summary: Microprocessor-Controlled Knee

The literature consists of a number of small within-subject comparisons of microprocessor-controlled knees with non-microprocessor-controlled knee joints. Studies of prostheses with microprocessor knees in Medicare-level K3 and K4 amputees have shown objective improvements in function on some outcome measures and strong patient preference for the microprocessor-controlled prosthetic knees. The evidence in Medicare level K2 ambulators suggests that a prosthesis with stance control only can improve activities that require balance and improve walking in this population. Only 1 biomechanical study of the next-generation Genium prosthesis was identified. One small study found little difference in performance between the Rheo Knee II and the user’s own non-microprocessor-controlled knee.

Powered Knee Prostheses

We did not identify any literature on powered knee prostheses.

Microprocessor-Controlled Ankle-Foot Prostheses

A Cochrane review by Hofstad et al (2004), which evaluated ankle-foot prostheses, concluded that there was insufficient evidence from high-quality comparative studies for an overall superiority of any individual type of prosthetic ankle-foot mechanism.^16,Also, reviewers noted that most clinical studies on human walking have used standardized gait assessment protocols (eg, treadmills) with limited “ecological validity,” and recommended that for future research, functional outcomes be assessed for various aspects of mobility such as making transfers, maintaining balance, level walking, stair climbing, negotiating ramps and obstacles, and changes in walking speed.

Proprio Foot

Gait analysis with the Proprio Foot was evaluated in 16 transtibial K3-K4 amputees during stair and ramp ascent and descent.^17,18, Results with the adaptive ankle (allowing 4° of dorsiflexion) were compared with tests conducted with the same prosthesis but at a fixed neutral angle (similar to other prostheses) and with results from 16 healthy controls. Adaptive dorsiflexion was found to increase during the gait analysis; however, this had a modest impact on other measures of gait for either the involved or uninvolved limb, with only a “tendency” to be closer to the controls, and the patient’s speed was not improved by the adapted ankle. The authors noted that an adaptation angle of 4° in the stair mode is small compared with physiologic ankle angles, and the lack of power generation with this quasi-passive design may also limit its clinical benefit. For walking up and down a ramp, the adapted mode resulted in a more normal gait during ramp ascent, but not during ramp descent. Some patients reported feeling safer with the plantar flexed ankle (adaptive mode) during ramp descent. Another small within-subject study (2014; n=6) found no benefit of an active Proprio Foot compared with the same prosthesis turned off with level walking or with slope ascent or descent.^19,

Self-reported and objective performance outcomes for 4 types of prosthetic feet, including the Proprio Foot, were evaluated in a randomized within-subject crossover study reported by Gailey et al (2012).^20, Ten patients with transtibial amputation were initially tested with their prosthesis and tested again following training and a 2-week acclimation period with the SACH (solid ankle cushion heel), SAFE (stationary attachment flexible endoskeletal), Talux, and Proprio Foot in a randomized order. No differences between prostheses were detected by the self-reported Prosthesis Evaluation Questionnaire and Locomotor Capabilities Index, or for the objective 6-minute walk test. Steps per day and hours of daily activity between testing sessions did not differ by type of prosthesis.

Another study by Delussu et al (2013) found a lower energy cost of floor walking with the Proprio Foot compared with a dynamic carbon fiber foot in 10 transtibial amputees.^21, However, the study found no significant benefit for walking stairs or ramps, for the Timed Up & Go test, or for perceived mobility or walking ability.

Section Summary: Microprocessor-Controlled Ankle-Foot Prostheses

Several small studies have been reported with microprocessor-controlled prostheses for transtibial amputees. The evidence to date is insufficient to support an improvement in functional outcomes compared with the same device in the off-mode or compared with energy-storing and -returning (ESR) prostheses. Larger, higher quality studies are needed to determine the impact of these devices on health outcomes with greater certainty.

Powered Ankle-Foot Prostheses

PowerFoot BiOM

Au et al (2008) reported on the design and development of the powered ankle-foot prosthesis (PowerFoot BiOM); however, clinical evaluation of the prototype was performed in a single patient.^22,

Ferris et al (2012) reported on a pre-post comparison of the PowerFoot BiOM with the patient’s own ESR foot in 11 patients with transtibial amputation. Results for both prostheses were also compared with 11 matched controls who had intact limbs.^23, In addition to altering biomechanical measures, the powered ankle-foot increased walking velocity compared with the ESR prosthesis and increased step length compared with the intact limb. There appeared to be an increase in compensatory strategies at proximal joints with the PowerFoot; the authors noted that normalization of gait kinematics and kinetics might not be possible with a uniarticular device. Physical performance measures did not differ significantly between the prostheses, and there were no significant differences between conditions on the Prosthesis Evaluation Questionnaire. Seven patients preferred the PowerFoot and 4 preferred the ESR. Compared with controls with intact limbs, the PowerFoot had reduced range of motion but provided greater ankle peak power.

In another similar, small pre-post study (7 amputees, 7 controls), Herr and Grabowski (2012) found gross metabolic cost and preferred walking speed to be more similar to nonamputee controls with the PowerFoot BiOM than with the patient’s own ESR.^24,

In a conference proceeding, Mancinelli et al (2011) described a comparison of a passive-elastic foot and the PowerFoot BiOM in 5 transtibial amputees.^25,The study was supported by the U.S. Department of Defense, and, at the time of testing, the powered prosthesis was a prototype and subjects’ exposure to the prosthesis was limited to the laboratory. Laboratory assessment of gait biomechanics showed an average increase of 54% in the peak ankle power generation during late stance. Metabolic cost, measured by oxygen consumption while walking on an indoor track, was reduced by an average of 8.4% (p=0.06).

Section Summary: Powered Ankle-Foot Prostheses

Several small studies have been reported with powered ankle-foot prostheses for transtibial amputees. The evidence to date is insufficient to support an improvement in functional outcomes.

Summary of Evidence

For individuals who have a transfemoral amputation who receive a prosthesis with a microprocessor-controlled knee, the evidence includes a number of within-subject comparisons of microprocessor-controlled knees vs non-microprocessor-controlled knee joints. Relevant outcomes are functional outcomes, health status measures, and quality of life. For K3- and K4-level amputees, studies have shown an objective improvement in function on some outcome measures, particularly for hill and ramp descent, and strong patient preference for microprocessor-controlled prosthetic knees. Benefits include a more normal gait, an increase in stability, and a decrease in falls. The evidence in Medicare level K2 ambulators suggests that a prosthesis with stance control only can improve activities that require balance and improve walking in this population. For these reasons, a microprocessor-controlled knee may provide incremental benefit for these individuals. The potential to achieve a higher functional level with a microprocessor-controlled knee includes having the appropriate physical and cognitive ability to use the advanced technology. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have a transfemoral amputation who receive a prosthesis with a powered knee, the evidence includes limited data. Relevant outcomes are functional outcomes, health status measures, and quality of life. The limited evidence available to date does not support an improvement in functional outcomes using a powered knee prostheses with standard prostheses. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have a tibial amputation who receive a prosthesis with a microprocessor-controlled ankle-foot, the evidence includes limited data. Relevant outcomes are functional outcomes, health status measures, and quality of life. The limited evidence available to date does not support an improvement in functional outcomes using microprocessor-controlled ankle-foot prostheses compared with standard prostheses. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have a tibial amputation who receive a prosthesis with a powered ankle-foot, the evidence includes no data. Relevant outcomes are functional outcomes, health status measures, and quality of life. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statements

The Veteran’s Affairs Prosthetic and Sensory Aids Strategic Healthcare Group established a Prosthetic Clinical Management Program to coordinate the development of clinical practice recommendations for prosthetic prescriptive practices.^26, A subgroup of the Pre-Post National Amputation Workgroup met in 2004 to define the patient selection and identification criteria for microprocessor prosthetic knees. Their proposal was based on recommendations arising from the 2003 Microprocessor Prosthetic Knee Forum. The resulting Department of Veterans Affairs clinical practice recommendations for microprocessor knees are listed in the Appendix.

U.S. Preventive Services Task ForceRecommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 3.

Table 3. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
Unpublished
NCT02864693	Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Energy Storing and Returning Prosthetic Feet in Persons With Unilateral Transtibial Amputation	30	Apr 2018

NCT: national clinical trial.

^a Denotes industry-sponsored or cosponsored trial.]
________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Microprocessor-Controlled Prostheses for the Lower Limb
Microprocessor-Controlled Lower Limb Prosthesis for Above-the-Knee (Transfemoral) Amputees
Microprocessor-Controlled Prosthetic Knees
Lower Limb Prosthesis, Microprocessor-Controlled
Leg Prosthesis, Microprocessor-Controlled
C-Leg
C Leg
C-Leg Compact
Intelligent Prosthesis
Adaptive
Rheo
iPed
Power Foot
Power Knee
Proprio Foot
Myoelectric Prosthesis for the Lower Limb
PowerFoot Biom
Genium
Prostheses for the Lower Limb, Microprocessor-Controlled

References:
1. Flynn K. Short Report: Computerized lower limb prosthesis (VA Technology Assessment Program). No. 2. Boston, MA: Veterans Health Administration; 2000.

2. Theeven P, Hemmen B, Rings F, et al. Functional added value of microprocessor-controlled knee joints in daily life performance of Medicare Functional Classification Level-2 amputees. J Rehabil Med. Oct 2011;43(10):906- 915. PMID 21947182.

3. Theeven PJ, Hemmen B, Geers RP, et al. Influence of advanced prosthetic knee joints on perceived performance and everyday life activity level of low-functional persons with a transfemoral amputation or knee disarticulation. J Rehabil Med. May 2012;44(5):454-461. PMID 22549656.

4. Burnfield JM, Eberly VJ, Gronely JK, et al. Impact of stance phase microprocessor-controlled knee prosthesis on ramp negotiation and community walking function in K2 level transfemoral amputees. Prosthet Orthot Int. Mar 2012;36(1):95-104. PMID 22223685.

5. Orendurff MS, Segal AD, Klute GK, et al. Gait efficiency using the C-Leg. J Rehabil Res Dev. Mar-Apr 2006;43(2):239-246. PMID 16847790.

6. Klute GK, Berge JS, Orendurff MS, et al. Prosthetic intervention effects on activity of lower-extremity amputees. Arch Phys Med Rehabil. May 2006;87(5):717-722. PMID 16635636.

7. Williams RM, Turner AP, Orendurff M, et al. Does having a computerized prosthetic knee influence cognitive performance during amputee walking? Arch Phys Med Rehabil. Jul 2006;87(7):989-994. PMID 16813788.

8. Hafner BJ, Smith DG. Differences in function and safety between Medicare Functional Classification Level-2 and -3 transfemoral amputees and influence of prosthetic knee joint control. J Rehabil Res Dev. Aug 2009;46(3):417- 433. PMID 19675993.

9. Highsmith MJ, Kahle JT, Miro RM, et al. Ramp descent performance with the C-Leg and interrater reliability of the Hill Assessment Index. Prosthet Orthot Int. Oct 2013;37(5):362-368. PMID 23327837.

10. Howard CL, Wallace C, Perry B, et al. Comparison of mobility and user satisfaction between a microprocessor knee and a standard prosthetic knee: a summary of seven single-subject trials. Int J Rehabil Res. Mar 2018;41(1):63-73. PMID 29293160.

11. Hafner BJ, Willingham LL, Buell NC, et al. Evaluation of function, performance, and preference as transfemoral amputees transition from mechanical to microprocessor control of the prosthetic knee. Arch Phys Med Rehabil. Feb 2007;88(2):207-217. PMID 17270519.

12. Kaufman, KK, Bernhardt, KK, Symms, KK. Functional assessment and satisfaction of transfemoral amputees with low mobility (FASTK2): A clinical trial of microprocessor-controlled vs. non-microprocessor-controlled knees. Clin Biomech (Bristol, Avon), 2018 Aug 5;58:116-122. PMID 30077128.

13. Kaufman KR, Levine JA, Brey RH, et al. Gait and balance of transfemoral amputees using passive mechanical and microprocessor-controlled prosthetic knees. Gait Posture. Oct 2007;26(4):489-493. PMID 17869114.

14. Kaufman KR, Levine JA, Brey RH, et al. Energy expenditure and activity of transfemoral amputees using mechanical and microprocessor-controlled prosthetic knees. Arch Phys Med Rehabil. Jul 2008;89(7):1380-1385. PMID 18586142.

15. Johansson JL, Sherrill DM, Riley PO, et al. A clinical comparison of variable-damping and mechanically passive prosthetic knee devices. Am J Phys Med Rehabil. Aug 2005;84(8):563-575. PMID 16034225.

16. Hofstad C, Linde H, Limbeek J, et al. Prescription of prosthetic ankle-foot mechanisms after lower limb amputation. Cochrane Database Syst Rev. Feb 2004(1):CD003978. PMID 14974050.

17. Alimusaj M, Fradet L, Braatz F, et al. Kinematics and kinetics with an adaptive ankle foot system during stair ambulation of transtibial amputees. Gait Posture. Oct 2009;30(3):356-363. PMID 19616436.

18. Fradet L, Alimusaj M, Braatz F, et al. Biomechanical analysis of ramp ambulation of transtibial amputees with an adaptive ankle foot system. Gait Posture. Jun 2010;32(2):191-198. PMID 20457526.

19. Darter BJ, Wilken JM. Energetic consequences of using a prosthesis with adaptive ankle motion during slope walking in persons with a transtibial amputation. Prosthet Orthot Int. Feb 2014;38(1):5-11. PMID 23525888.

20. Gailey RS, Gaunaurd I, Agrawal V, et al. Application of self-report and performance-based outcome measures to determine functional differences between four categories of prosthetic feet. J Rehabil Res Dev. Jul 2012;49(4):597-612. PMID 22773262.

21. Delussu AS, Brunelli S, Paradisi F, et al. Assessment of the effects of carbon fiber and bionic foot during overground and treadmill walking in transtibial amputees. Gait Posture. Sep 2013;38(4):876-882. PMID 23702342.

22. Au S, Berniker M, Herr H. Powered ankle-foot prosthesis to assist level-ground and stair-descent gaits. Neural Netw. May 2008;21(4):654-666. PMID 18499394.

23. Ferris AE, Aldridge JM, Rabago CA, et al. Evaluation of a powered ankle-foot prosthetic system during walking. Arch Phys Med Rehabil. Nov 2012;93(11):1911-1918. PMID 22732369.

24. Herr HM, Grabowski AM. Bionic ankle-foot prosthesis normalizes walking gait for persons with leg amputation. Proc Biol Sci. Feb 7 2012;279(1728):457-464. PMID 21752817.

25. Mancinelli C, Patritti BL, Tropea P, et al. Comparing a passive-elastic and a powered prosthesis in transtibial amputees. Conf Proc IEEE Eng Med Biol Soc. Aug 2011;2011:8255-8258. PMID 22256259.

26. Berry D. Microprocessor prosthetic knees. Phys Med Rehabil Clin N Am. Feb 2006;17(1):91-113, vii. PMID 16517347.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

L5856
L5857
L5858
L5859
L5973
L5999