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New smart knee aims to make stairs easier for amputees

NCT ID NCT05523349

Symptom relief Sponsor: Össur Iceland ehf Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tested a new microprocessor-controlled prosthetic knee called NAVii in 14 people with leg amputations. Participants tried the new knee and then their usual knee, and researchers compared how satisfied they were walking downstairs and how far they could walk in six minutes. The goal was to see if the new knee performs better than existing options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NAVii passive microprocessor-controlled prosthetic knee
What this could lead to
If this knee works well, it could offer amputees a new option for easier stair descent and walking.
What could go wrong
This was a very small study with only 14 people, so results may not apply to everyone. It also only compared satisfaction and walking distance, not long-term benefits.

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

14 people

The number who actually took part.

Started

Aug 2022

Finished

Sep 2022

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: * 45Kg\< body weight \< 136Kg * Cognitive ability to understand all instructions and questionnaires in the study; * Unilateral TF/KD amputees that are regular prosthesis users for at least 3 months * Current MPK users (passive MPKs only) * Age ≥ 18 years * Willing and able to participate in the study and follow the protocol * Moderate to high active users (PLUS M T-score\>4021) Exclusion Criteria: * Users with stump pain * Users with socket problems * Pregnant Users * Users using Power Knee, Kenevo or mechanical knees as their prescribed prosthesis * Alignment that cannot be matched with the Rheo Knee 4 setup, as described in Instructions for use. * Osseointegration

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As listed by the trial registrant

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

Amputation Prosthesis user

Contacts and locations

Locations

  • Bionic P & O

    Merrillville, Indiana, 46410, United States

  • Oakland Orthopedic appliances

    Bay City, Michigan, 48708, United States

  • Ossur Motionlab

    Reykjavik, 110, Iceland

  • Perry Prosthetics

    Perrysburg, Ohio, 43551, United States

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