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Bionic knees vs. standard: which helps amputees walk better?

NCT ID NCT06194838

Knowledge-focused Sponsor: Liberating Technologies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether powered prosthetic knees help people with above-knee amputations walk more and feel more confident than standard non-powered knees. Twenty-six adults who already use a mechanical knee will try both types at home for three months each. Researchers will track step counts and balance confidence to see which knee works best in real life.

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 III or Reboocon Intuy Knee)
What this could lead to
If successful, this could help doctors prescribe the right prosthetic knee for each patient, improving mobility and confidence.
What could go wrong
This is a small early-stage study with only 26 participants, so results may not apply to everyone. The devices may not show clear benefits over standard knees.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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 * Transfemoral prosthesis user (limb absence between the knee and hip) * Current user of a mechanical knee * Regularly wears prosthesis at least 5 days per week * Have adequate clearance between distal end and ground for necessary knee and foot components * Current Medicare Functional Classification Level (K-Level) of 2 as determined by the healthcare team * Socket-Comfort Score: 6 or above to ensure adequate socket fit * Six months or more experience on a prosthesis * Body weight between 50kg and 116kg (110lbs - 256lbs) * Height between 1.2m and 1.95m (47.2in and 76.8in) * Has a phone to answer periodic study calls Exclusion Criteria: * Present injuries to residual limb or contralateral leg affecting functional ability * Contralateral amputation proximal to MTP (metatarsophalangeal) joint * Socket issues/changes in the last 6 weeks * Users with bone-anchored implants * Health or medical condition, diagnosis, or other cause that would prevent participant from effectively following study protocol, performing required outcome measures, and/or completing the study Subjects can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.). If subjects experience a health or medical condition that leaves them immobile for more than 2 weeks, they may be given the option to restart the study condition upon recovery, as long as eligibility criteria is still met, and comparable baseline functionality is demonstrated with outcomes measures. 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.

amelia of lower limb injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hanger Clinic

    RECRUITING

    Austin, Texas, 78758, United States

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