Actively Recruiting
Biomechanical Evaluation of the Ossur Power Knee Compared to Ossur Rheo XC in Transfemoral Amputees
Led by VA Office of Research and Development · Updated on 2025-09-09
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the biomechanical effects of the Ossur Power Knee, a microprocessor-controlled prosthetic knee with active motor-driven flexion and extension, compared to the Ossur Rheo XC, a passive microprocessor-controlled knee. The study focuses on unilateral transfemoral amputees aged 45 to 75 years, aiming to evaluate differences in walking and mobility, including a comparison by gender to identify any sex-specific prosthesis needs. The research is designed to improve understanding of prosthetic knee function and enhance prosthesis selection for users. Participants will be fitted with both the Ossur Power Knee and the Ossur Rheo XC in a crossover design, receiving one month of accommodation with each device before evaluation. The Power Knee provides powered knee flexion and extension, while the Rheo XC modulates damping passively during movement. Subjects will perform walking, stair climbing, slope navigation, and sit-to-stand activities while wearing each knee. Questionnaires and at-home diaries will capture user perceptions of comfort, exertion, and stability. During the study, detailed biomechanical data such as walking speed, metabolic energy cost, symmetry during sit-to-stand movements, step length, toe clearance, leg loading, and pelvic motion will be collected. Assessments occur after each one-month accommodation period. The study uses motion analysis labs for gait data and includes participant self-reporting. The total participation timeline includes fitting, training, accommodation, and evaluation phases for both knee types, allowing each participant to serve as their own control.
CONDITIONS
Brief Title
A Biomechanical Evaluation of the Ossur Power Knee in Persons With Transfemoral Amputation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral transfemoral amputation of any cause
- Age between 45 and 75 years
- Residual limb length classified as standard (medium) to long
- Use of a prosthesis for at least 1 year before enrolling
- Ambulator at K3 or K4 level
- Good sensation in residual limb on clinical exam
- Good skin condition on residual limb
- Able to walk short distances without assistive devices
- Not currently taking medications that affect balance or walking
- Good socket fit as confirmed by study prosthetist
You will not qualify if you...
- Bilateral amputations
- Knee disarticulation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month per prosthetic knee
Participants are fitted and trained on each prosthetic knee (Ossur Power Knee and Ossur Rheo XC Knee) and use each device for an accommodation period before evaluation.
1 fitting and training visit per knee
Duration - Evaluation after each 1-month accommodation period
Participants are evaluated biomechanically in the laboratory while wearing each prosthetic knee after the accommodation periods. This includes walking and performing activities such as stairs and sit-to-stand movements, along with completing questionnaires and diaries about comfort and stability.
2 evaluation visits (one per prosthetic knee)
Trial Site Locations
Total: 1 location
1
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
R
Rebecca Stine, MS
S
Steven A Gard, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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