Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

Study Overview
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Brief Summary
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Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee disarticulation level amputation categorized as K2 ambulators.

Detailed Description
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Randomized controlled trial investigating the benefits of microprocessor controlled knee prostheses (MPK) in patients with a transfemoral or knee disarticulation level amputation categorized by Medicare Functional Classification Level (MFCL) as a Limited Community Ambulator (K-Level 2). There are two aims for the study. Aim 1 is to understand the effect of MPK technology for the K2 ambulator on reducing fear and anxiety of falling, improving health-related quality of life, and participation in society and activities. Aim 2 is to understand the long-term effect of MPK technology the aspects from Aim 1 as well as reducing morbidity. The trial will be conducted in two phases. Phase 1 will cover the initial 12-month period to address Aim 1, and phase 2 will monitor from 12 months to 5 years to address Aim 2.

Official Title
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Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

Conditions
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Lower Limb Amputation Above Knee (Injury), Congenital Amputation of Lower Limb, Lower Limb Amputation Knee

Intervention / Treatment
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* Device: Kenevo or C-Leg 4
* Device: Non microprocessor controlled knee (NMPK)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral transfemoral or knee disarticulation amputation Received prosthesis between 4 - 24 months prior Currently uses prosthesis K2 ambulator status Able to speak English or Spanish language Age ≥ 65 years at Baseline Assessment (one month after enrollment) Minimum Socket Comfort Score (SCS) of 6/10 Exclusion Criteria: Upper limb involvement Individuals ≥ 275 lbs Unable to provide informed consent History of acute or chronic residual limb breakdown History of 2 or more socket adjustments or replacements in the past 6 months Amputation of the contralateral limb Active malignancy Rapidly declining health status resulting in reduced activity in the past 6 months, as determined by patient's clinician and confirmed by Clinical & Scientific Affairs personnel Patient unable or unwilling to follow study procedures Pregnant women, institutionalized persons, and children

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPK<br>Microprocessor controlled knee | Device: Kenevo or C-Leg 4<br>* Kenevo fitted to subjects walking slower than 0.8 m/s as measured by the 2-minute Walk Test. C-Leg 4 fitted to subjects walking faster than 0.8 m/s.<br>|
| Active Comparator: NMPK<br>Non-microprocessor controlled knee | Device: Non microprocessor controlled knee (NMPK)<br>* NMPK consistent with current standards of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Falling Avoidance Behavior Questionnaire (FFABQ) | This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling. | 12 months | 
| Fear of Falling Avoidance Behavior Questionnaire (FFABQ) | This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - 29 | The survey assessment comprises from 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social roles, and pain interference). The combined constructs serve to provide a measure of patient's quality of life. Raw scores are converted to T-scores which standardizes the scores with a mean of 50 and standard deviation of 10. Being above or below the standard deviation could be desirable or undesirable based on the domain being measured. Higher scores means more of the concept being measured (e.g. more fatigue). | 12 months | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA) | Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity. | 12 months | 
| 12-month fall count from bi-weekly fall journal | On a bi-weekly cadence, individuals will be asked to complete the Lower Limb Amputation Fall Survey. This survey was developed for the purpose of documenting number of falls and near-falls over a given period, as well as insight into the causality. | 12 months | 
| Average daily step counts | Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 12-month assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision. | 12 months | 
| Fear of Falling Avoidance Behavior Questionnaire (FFABQ) | This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling. | 3 years | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) - 29 | The survey assessment comprises from 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social roles, and pain interference). The combined constructs serve to provide a measure of patient's quality of life. Raw scores are converted to T-scores which standardizes the scores with a mean of 50 and standard deviation of 10. Being above or below the standard deviation could be desirable or undesirable based on the domain being measured. Higher scores means more of the concept being measured (e.g. more fatigue). | 5 years | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA) | Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity. | 5 years | 
| 10-meter Walk Test (10mWT) | The 10mWT is a standardized test of self-selected walking speed in which patients are timed over the middle 6 meters (19.7 feet) of a 10-meter (32.8 feet) flat walkway. The self-selected walking speed is calculated in meters per second and has been discussed as a potential vital sign given its strong relationship with survival. It will serve as a marker of morbidity. | 5 years | 
| Timed Up and Go (TUG) | The Timed Up-and-Go test is a standard basic mobility test that includes a sit-to-stand, gait initiation, walking, turning, and stand-to-sit. The test measures, in seconds, the time to stand up from an arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair and sit down. It is a measure of function, has been used to assess the risk of falling, and will serve as a marker of morbidity. | 5 years | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) - 29 | Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 5-year assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision. | 3 years | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA) | Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity. | 3 years | 
| 10-meter Walk Test (10mWT) | The 10mWT is a standardized test of self-selected walking speed in which patients are timed over the middle 6 meters (19.7 feet) of a 10-meter (32.8 feet) flat walkway. The self-selected walking speed is calculated in meters per second and has been discussed as a potential vital sign given its strong relationship with survival. It will serve as a marker of morbidity. | 3 years | 
| Timed Up and Go (TUG) | The Timed Up-and-Go test is a standard basic mobility test that includes a sit-to-stand, gait initiation, walking, turning, and stand-to-sit. The test measures, in seconds, the time to stand up from an arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair and sit down. It is a measure of function, has been used to assess the risk of falling, and will serve as a marker of morbidity. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prosthetic knee, lower limb amputation, microprocessor controlled knee, K2