Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis

Study Overview
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Brief Summary
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The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis.

Official Title
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Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis

Conditions
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Other and Unspecified Complications of Amputation Stump

Intervention / Treatment
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* Device: Otto Bock C-Leg
* Device: Otto Bock Genium


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Unilateral transfemoral or knee-disarticulation amputee 18 to 85 years of age K3 (variable cadence and community) ambulators; Current use of and experience with the C-Leg for at least 1 year Ability to descend stairs and hills without caregiver and assistive devices Be able to independently provide informed consent Be willing to comply with study procedures. Exclusion criteria: History of chronic skin breakdown on the residual limb Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking) Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate Unwillingness/inability to follow instructions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prosthetic knee 1 (Otto Bock C-Leg)<br>This arm included unilateral transfemoral amputees who were assessed while using their preferred knee at study start(C-Leg). The Otto Bock C-Leg is a microprocessor knee using 2 sensors (1 for kinetics and 1 for kinematics). | Device: Otto Bock C-Leg<br>* Amputees' preferred prosthetic knee.<br>|
| Active Comparator: Prosthetic knee 2 (Otto Bock Genium)<br>This arm included unilateral transfemoral amputees who were assessed while using the experimental/study knee, the Genium. The Otto Bock Genium is a microprocessor knee using multiple sensors that hypothetically increase mobility functions (e.g. walking backwards, intuitive stance) | Device: Otto Bock Genium<br>* Study knee.<br>|
| No Intervention: Non-amputee controls<br>This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 75 Meter Self Selected Walking Test | Time to Complete a 75 meter walking distance. | Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation. | 
| Physical Functional Performance (Continuous Scale; 10-items) | Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function. | Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance and Stability | Balance and stability will be assessed for limits of stability using the Biodex SD. The limit of stability score is a scaled score with a possible range of 0 (worst possible outcome) to 100 (best possible outcome)based on variability of the trajectory of the center of mass while weight shifting on a force platform. | Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation. | 
| Prosthesis Evaluation Questionnaire: Utility Score. | The Prosthetics Evaluation Questionnaire (PEQ) was used as a validated survey to solicit participants' subjective experience and feedback regarding prosthesis-related function and quality of life. PEQ domains are ordinally scaled from 0 (worst or most negative feeling/response) to 7 (best or most positive feeling/response). | Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation. |