Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees

Completed · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT05267639

Run by

Liberating Technologies, Inc.

People needed

13

Starts

2022-05-01

Expected to finish

2024-08-28

Last updated by the study team

2025-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Liberating Technologies, Inc. — Holliston, Massachusetts, United States
• Hanger Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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