Powered vs Conventional Prosthetic Knees for Amputation
(OPKTFA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Microprocessor-controlled knees (MPKs) do not typically utilize motors to power joint rotation, but they automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the prosthesis user during gait. The Ossur Power Knee is the only commercially-available MPK that uses a motor to provide active power generation during walking and other activities. The purpose of this proposed investigation is to perform and compare biomechanical evaluations of the Power Knee and Ossur Rheo XC, a passive MPK, during walking and other activities by prosthesis users. Furthermore, mobility between male and female subjects will be compared to determine if there are differences in prosthetic knee usage on the basis of sex.
Will I have to stop taking my current medications?
The trial requires that participants are not currently taking medications that affect balance or walking.
Is the powered prosthetic knee generally safe for humans?
Research shows that powered prosthetic knees, like the Ossur Power Knee, are designed to improve mobility and control for amputees, but specific safety data is not detailed in the available studies. However, microprocessor-controlled prosthetic knees have been found to offer safety benefits in community settings, suggesting that powered knees may also be safe.12345
How does the Ossur Power Knee treatment differ from conventional prosthetic knees for amputees?
The Ossur Power Knee is unique because it is a powered prosthetic knee that uses motors to provide active support, making movements like sitting down more controlled and less difficult for above-knee amputees. Unlike conventional passive prosthetic knees, which rely on resistive damper systems, the Power Knee can generate positive power, potentially improving mobility and reducing the need for over-compensation with other body parts.25678
What data supports the effectiveness of powered prosthetic knees for amputation?
Research shows that powered prosthetic knees, like the Ossur Power Knee, can improve mobility and reduce the strain on the hip muscles for people with above-knee amputations. They provide better control and support during movements like sitting down, compared to passive prosthetic knees, which can enhance overall functional mobility.12457
Who Is on the Research Team?
Steven A Gard, PhD
Principal Investigator
Jesse Brown VA Medical Center, Chicago, IL
Are You a Good Fit for This Trial?
This trial is for individuals with a transfemoral amputation, meaning they have had an amputation above the knee. Participants should be current users of a conventional prosthetic knee joint and willing to try out a powered prosthetic knee joint.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Accommodation
Participants undergo a 1-month accommodation period with each prosthetic knee component
Biomechanical Evaluation
Participants are evaluated for gait, stairs, slopes, and sit-to-stand activities using the Ossur Power Knee and Ossur Rheo XC
Follow-up
Participants are monitored for safety and effectiveness after the evaluation period
What Are the Treatments Tested in This Trial?
Interventions
- Conventional prosthetic knee joint
- Ossur Power Knee
Conventional prosthetic knee joint is already approved in United States, European Union, Canada for the following indications:
- Transfemoral amputation
- Lower limb amputation
- Transfemoral amputation
- Lower limb amputation
- Transfemoral amputation
- Lower limb amputation
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor