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Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees

NCT05267639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-06-26

Study results available
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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.

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

Interventions

DEVICE

Power Knee

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

Sponsors & Collaborators

  • Hanger Clinic: Prosthetics & Orthotics

    collaborator OTHER

  • Liberating Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Johansson, MS · Liberating Technologies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-08-28
Completion
2024-08-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05267639 on ClinicalTrials.gov