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

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated September 3, 2025 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Aug 31, 2025 to Aug 31, 2026v5
  2. Secondary endpoints shortened, about 95 wordsv4
  3. Re-verified, no change to tracked fieldsv3
  4. Primary endpoints revised (3)
    • Secondary endpoints revised (11)
    • Study description shortened, about 258 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06194838
Lead Sponsor Liberating Technologies, Inc.
Collaborators: Hanger Clinic: Prosthetics & Orthotics
Conditions
(from sponsor)		 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
Related terms Wounds and Injuries
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov