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

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., choosing the right device to maximize the benefit for each patient). The investigators intend to use this trial data along with a concurrent study being conducted within the K3-K4 level population to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with the current standard in TFA populations is needed to allow for improved clinical decision making and clinical outcomes.

NCT Number	NCT06194838
Lead Sponsor	Liberating Technologies, Inc. Collaborators: Hanger Clinic: Prosthetics & Orthotics
Conditions	Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower, Prosthesis User, Lower Limb Amputation Above Knee (Injury), Amputation; Traumatic, Leg: Thigh, Between Hip and Knee
Enrollment	26 participants
Start Date	2023-09-12
Primary Completion	2026-08-31 (estimated)
Study Completion	2026-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-03