Evaluating the Ossur Power Knee for people with above-knee amputations
Do Transfemoral Prostheses With Powered Prosthetic Knee Flexion and Extension Improve Mobility? A Biomechanical Evaluation of the Ossur Power Knee
This study is testing whether the Ossur Power Knee, a high-tech prosthetic knee that helps with movement, works better than a regular prosthetic knee for people with above-knee amputations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06218238 on ClinicalTrials.gov |
What this trial studies
This investigation aims to biomechanically evaluate the Ossur Power Knee, a microprocessor-controlled prosthetic knee that actively generates power during movement, and compare its performance to the Ossur Rheo XC, a conventional passive prosthetic knee. The study will assess how these devices affect walking and other activities in individuals with unilateral transfemoral amputation. Additionally, it will explore potential differences in mobility between male and female users. Participants will be monitored for their gait and overall mobility to determine the effectiveness of the powered knee joint.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45-75 with unilateral transfemoral amputation who have been using a prosthesis for at least one year.
Not a fit: Patients with bilateral amputations or knee disarticulations will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mobility and quality of life for individuals with transfemoral amputations.
How similar studies have performed: Previous studies on microprocessor-controlled knees have shown promising results, indicating potential advancements in prosthetic technology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral, transfemoral amputation (any etiology). * Age from 45-75 years. * Residual limb length classified as standard (i.e., medium) to long. * Prosthesis user for at least 1 year prior to enrolling in the study. * K3 or K4 level ambulator. * Good sensation on their residual limb(s) (upon routine clinical examination). * Good skin integrity upon visual inspection. * Does not require the use of assistive devices to walk for short distances. * Not currently taking medications that are known to affect balance or gait. * Presents with good socket fit based upon a standard assessment by the study prosthetist. Exclusion Criteria: * Bilateral amputations * Individuals with a knee disarticulation
Where this trial is running
Chicago, Illinois
- Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Steven A Gard, PhD — Jesse Brown VA Medical Center, Chicago, IL
- Study coordinator: Rebecca Stine, MS
- Email: rebecca.stine@va.gov
- Phone: (312) 503-5726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.