Actively Recruiting
Clinical Outcomes Associated With At Home Use of Non-Powered vs. Powered Prosthetic Knees by K2-level Individuals With Transfemoral Amputations
Led by Liberating Technologies, Inc. · Updated on 2025-09-03
26
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Liberating Technologies, Inc.
Lead Sponsor
H
Hanger Clinic: Prosthetics & Orthotics
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to collect community-based data from individuals with transfemoral amputations at the K2 functional level to better understand how powered prosthetic knees compare with mechanical knees in daily life. The study focuses on helping doctors choose the most suitable knee prosthesis for each patient, improving clinical decisions and outcomes. The findings will also inform future prosthetic knee designs by identifying valuable features for users outside laboratory settings. The study compares three types of prosthetic knees: the Ossur Power Knee, a powered knee; the Reboocon Intuy Knee, another powered knee; and the Ossur OFM-2, a passive mechanical knee commonly used by K2 users. Participants will randomly try each knee for three months, starting with a training and acclimation period followed by home use. The order of knee use is randomized to reduce seasonal effects, and participants will use a standardized prosthetic ankle/foot throughout the study. Participants will attend training sessions, complete functional tests, and fill out self-report surveys during each knee condition. An activity monitor will track daily step counts, and researchers will periodically check for falls. Each condition lasts three months, with assessments conducted at the start and end of each period. The total study duration for each participant is approximately nine months, and safety and performance outcomes will be monitored throughout.
CONDITIONS
Brief Title
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 of 6 or above for 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
You will not qualify if you...
- Present injuries to residual limb or contralateral leg affecting functional ability
- Contralateral amputation proximal to metatarsophalangeal (MTP) joint
- Socket issues or changes in the last 6 weeks
- Users with bone-anchored implants
- Health or medical conditions preventing effective study participation, outcome performance, or study completion
- Pregnant women
- Other unforeseen disqualifying criteria at investigator's discretion
- Immobility for more than 2 weeks unless allowed to restart the condition after recovery
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 knee condition
Participants are fit and aligned on each prosthetic knee by a trained prosthetist, then trained on the device to learn proper use and demonstrate proficiency through multiple training sessions.
4 to 8 training sessions of 1 hour each per knee condition
Duration - 3 months per knee condition
Participants wear each prosthetic knee at home full time to assess real-world use and functional outcomes.
Regular phone calls for fall monitoring during at-home use
Duration - Short visits after each 3-month wear period
Participants return to the clinic for functional tests and self-report surveys after each knee condition to evaluate outcomes.
1 visit per knee condition (in-person) for outcome assessments
Trial Site Locations
Total: 1 location
1
Hanger Clinic
Austin, Texas, United States, 78758
Actively Recruiting
Research Team
S
Shane Wurdeman, PhD
J
Jennifer Johansson, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
3
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