Can a motorized knee help amputees walk more? trial puts it to the test
NCT ID NCT05267639
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are comparing a powered prosthetic knee with a standard microprocessor-controlled knee in people who have an above-knee amputation and are highly active. Participants will use each knee for three months while wearing an activity monitor to track daily steps. The study also measures balance confidence and well-being through questionnaires. The goal is to gather real-world data that could help doctors choose the best prosthetic knee for each patient.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Powered prosthetic knee (Ossur Power Knee)
- What this could lead to
- If powered knees help, this could guide doctors to prescribe the right prosthetic knee for each patient, improving mobility and confidence for people with above-knee amputations.
- What could go wrong
- This is a small study of 13 highly active participants, so the results may not apply to less active amputees. Powered knees are complex and expensive, and they may not outperform simpler devices for everyone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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13 people
The number who actually took part.
- Started
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May 2022
- Finished
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Aug 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Are at least 18 years old * Unilateral transfemoral prosthesis user (limb absence between the knee and hip) * Current user of a microprocessor-controlled knee (MPK) * Have adequate clearance between distal end and ground for necessary knee and foot components * Medicare Functional Classification Level (K-Level): 4 * Socket-Comfort Score: 6 or above to ensure adequate socket fit * PLUS-M T-score of 55 or above * Six months or more experience on a prosthesis * Body weight between 50kg and 116kg (110lbs - 256lbs) Exclusion Criteria: * Present injuries to residual limb or contralateral leg affecting functional ability * Socket issues/changes in the last 6 weeks * Users with bone-anchored implants Subjects can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.). Subjects in this study will not be discriminated by sex/gender or race/ethnicity. Using a knee that the subject is unfamiliar with may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by self-disclosure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hanger Clinic
Austin, Texas, 78758, United States
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Liberating Technologies, Inc.
Holliston, Massachusetts, 01746, United States
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Other studies related to the condition(s) this trial covers.
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