Status:
COMPLETED
Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees
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 K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., cho...
Detailed Description
The goal of this proposed project is to gather community-based data from the K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., cho...
Eligibility Criteria
Inclusion
- Are at least 18 years old
- Unilateral transfemoral prosthesis user (limb absence between the knee and hip)
- Current user of a microprocessor-controlled knee (MPK)
- Have adequate clearance between distal end and ground for necessary knee and foot components
- Medicare Functional Classification Level (K-Level): 4
- Socket-Comfort Score: 6 or above to ensure adequate socket fit
- PLUS-M T-score of 55 or above
- Six months or more experience on a prosthesis
- Body weight between 50kg and 116kg (110lbs - 256lbs)
Exclusion
- Present injuries to residual limb or contralateral leg affecting functional ability
- Socket issues/changes in the last 6 weeks
- Users with bone-anchored implants
- Subjects can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.). Subjects in this study will not be discriminated by sex/gender or race/ethnicity.
- 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 :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05267639
Start Date
May 1 2022
End Date
August 28 2024
Last Update
June 26 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Liberating Technologies, Inc.
Holliston, Massachusetts, United States, 01746
2
Hanger Clinic
Austin, Texas, United States, 78758