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NCT05267639 · ClinicalTrials.gov registry record · NA
Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees
A NA study of Amputation and Prosthesis User, sponsored by Liberating Technologies.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
- 2
- Study locations
NCT05267639: Completed NA study of Amputation and Prosthesis User, sponsored by Liberating Technologies.
NCT05267639 is a NA study of Amputation and Prosthesis User that has completed, run by Liberating Technologies. The registered enrollment target is 13 participants, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05267639, a NA study of Amputation and Prosthesis User, has completed, sponsored by Liberating Technologies.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Prior to each condition, each subject will be fit and aligned on the designated knee by a trained certified prosthetist. An activity monitor (such as the GeneActiv™) will be worn by the subject for each intervention period during the final month of the condition. Similar to prior studies, the investigators will use the activity monitor to track the number of steps the subjects take in each condition per day. The number of steps per day are averaged over the final month in each condition. A high
Conditions Studied
Interventions
- DEVICE Power Knee
Study Locations (2)
Massachusetts
- Liberating Technologies, Inc. - Holliston
Texas
- Hanger Clinic - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2024-08-28 |
| Phase | NA |
What the finished NCT05267639 record still lists
NCT05267639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (90% lower).
The record links to 6 conditions, with Amputation appearing as the primary indexed condition, and to 1 intervention - of which Power Knee is the first listed.
NCT05267639 reports a single indexed study location in Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT05267639 about?
NCT05267639 is a clinical study titled "Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees". 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 th...
What is the current status of trial NCT05267639?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2022-05-01. Estimated completion is 2024-08-28.
What conditions does trial NCT05267639 study?
This clinical trial studies the following conditions: Amputation, Prosthesis User, Lower Limb Amputation Above Knee (Injury), Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower.
What interventions are being tested in trial NCT05267639?
The interventions under investigation include: Power Knee (DEVICE).
Who is sponsoring clinical trial NCT05267639?
This trial is sponsored by Liberating Technologies, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05267639 being conducted?
This trial has 2 study locations across Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05267639's enrollment target sits among peer trials
13 47th of 65 higher than 19 of 65 other Amputation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amputation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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