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COMPLETED
NCT05267639
NA

Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees

Sponsor: Liberating Technologies, Inc.

View on ClinicalTrials.gov

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., choosing the right device to maximize the benefit for each patient). The investigators envision that this Level 1 submission will transition into a larger follow-on Level 2 trial that will explore a larger spectrum of patient populations (K2-K4), as well as testing additional Power Knees currently in development that are expected to become commercialized in the near future. The investigators intend to use this Level 2 trial data 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 MPKs is needed to allow for improved clinical decision making and clinical outcomes.

Official title: Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees by K4-level Transfemoral Amputees

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2022-05-01

Completion Date

2024-08-28

Last Updated

2026-09-17

Healthy Volunteers

Yes

Interventions

DEVICE

Power Knee

Newest version of the commercially-available Power Knee developed by Ossur.

Locations (2)

Liberating Technologies, Inc.

Holliston, Massachusetts, United States

Hanger Clinic

Austin, Texas, United States