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

Part of paid clinical trials in Austin, Texas.

Sponsor
Liberating Technologies, Inc.
Study ID
NCT06194838
Status
Recruiting
Apply to this trial

Conditions

  • Amputation
  • Amputation; Traumatic, Leg, Lower
  • Amputation; Traumatic, Leg: Thigh, Between Hip and Knee
  • Limb; Absence, Congenital, Lower
  • Lower Limb Amputation Above Knee (Injury)
  • Prosthesis User

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ossur Power Knee — DEVICE
    Newest version of the commercially-available powered knee developed by Ossur.
  • Reboocon Intuy Knee — DEVICE
    Commercially-available powered knee developed by Reboocon.

Study Details

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.

Key Dates

Start date
Sep 12, 2023
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • No Intervention: Comparator Baseline
    The subject will wear the Ossur OFM-2, a passive mechanical knee which is the most commonly used knee for K2 users, for 3 months, as well as in the lab to complete outcome measures.
  • Experimental: Ossur Power Knee
    The subject will wear the Ossur Power Knee for 3 months, as well as in the lab to complete outcome measures.
  • Experimental: Reboocon Intuy Knee
    The subject will wear the Reboocon Intuy Knee for 3 months, as well as in the lab to complete outcome measures.

Primary Outcome Measure

Step count [ Time Frame: Monitored over entire study (9 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hanger ClinicAustinTexas78758
Shane Wurdeman, PhD
[email protected]
402-290-8051
Siya Asatkar
[email protected]
512-774-7105

Find similar trials in Austin, TX

By research site
Hanger Clinic· Austin, TX

Related Studies