Status:
RECRUITING
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
Lead Sponsor:
Liberating Technologies, Inc.
Collaborating Sponsors:
Hanger Clinic: Prosthetics & Orthotics
Conditions:
Amputation
Amputation; Traumatic, Leg, Lower
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., cho...
Detailed Description
This study will focus on investigating the tradeoffs between powered knees and mechanical knees to identify the prosthetic knee that is best suited for K2 users during different tasks. The investigato...
Eligibility Criteria
Inclusion
- Are at least 18 years old
- Transfemoral prosthesis user (limb absence between the knee and hip)
- Current user of a mechanical knee
- Regularly wears prosthesis at least 5 days per week
- Have adequate clearance between distal end and ground for necessary knee and foot components
- Current Medicare Functional Classification Level (K-Level) of 2 as determined by the healthcare team
- Socket-Comfort Score: 6 or above to ensure adequate socket fit
- Six months or more experience on a prosthesis
- Body weight between 50kg and 116kg (110lbs - 256lbs)
- Height between 1.2m and 1.95m (47.2in and 76.8in)
- Has a phone to answer periodic study calls
Exclusion
- Present injuries to residual limb or contralateral leg affecting functional ability
- Contralateral amputation proximal to MTP (metatarsophalangeal) joint
- Socket issues/changes in the last 6 weeks
- Users with bone-anchored implants
- Health or medical condition, diagnosis, or other cause that would prevent participant from effectively following study protocol, performing required outcome measures, and/or completing the study
- Subjects can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.).
- If subjects experience a health or medical condition that leaves them immobile for more than 2 weeks, they may be given the option to restart the study condition upon recovery, as long as eligibility criteria is still met, and comparable baseline functionality is demonstrated with outcomes measures.
- Using a knee that the subject is unfamiliar with may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by self-disclosure.
Key Trial Info
Start Date :
September 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06194838
Start Date
September 12 2023
End Date
August 31 2026
Last Update
September 3 2025
Active Locations (1)
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1
Hanger Clinic
Austin, Texas, United States, 78758