Comparing Clinical Outcomes of Non-Powered and Powered Prosthetic Knees in K2-Level Adults with Transfemoral Amputations

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 anklefoot 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.

Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees