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

NCT06194838 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-09-03

No results posted yet for this study

Summary

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.

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

Ossur Power Knee

Newest version of the commercially-available powered knee developed by Ossur.

DEVICE

Reboocon Intuy Knee

Commercially-available powered knee developed by Reboocon.

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
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2026-08-31
Completion
2026-08-31
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 NCT06194838 on ClinicalTrials.gov