NCT06218238 A Biomechanical Evaluation of the Ossur Power Knee in Persons With Transfemoral Amputation
| NCT ID | NCT06218238 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Transfemoral Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-04-01 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Steven A Gard, PhD
PRINCIPAL INVESTIGATOR
Jesse Brown VA Medical Center, Chicago, IL
Frequently Asked Questions
Who can join the NCT06218238 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Transfemoral Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06218238 currently recruiting?
Yes, NCT06218238 is actively recruiting participants. Contact the research team at rebecca.stine@va.gov for enrollment information.
Where is the NCT06218238 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06218238 clinical trial?
NCT06218238 is sponsored by VA Office of Research and Development. The principal investigator is Steven A Gard, PhD at Jesse Brown VA Medical Center, Chicago, IL. The trial plans to enroll 20 participants.