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New bionic knee aims to make stairs and ramps easier for amputees

NCT ID NCT06748729

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new microprocessor-controlled prosthetic knee (Navii Knee) in 11 people with above-knee amputations. Participants used the new knee for 4 weeks at home, and researchers measured satisfaction with stair and ramp descent, walking, balance, and overall quality of life. The goal was to see if the new knee performed as well as or better than their usual device.

What this could mean

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

Active substance
Navii Knee (microprocessor-controlled prosthetic knee)
What this could lead to
If it works, this could offer amputees a more satisfying and stable knee for walking on slopes and stairs.
What could go wrong
This was a very small study (11 people) with no statistical testing, so results may not apply to everyone. The device may not improve mobility for all users.

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

11 people

The number who actually took part.

Started

Feb 2024

Finished

Mar 2024

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 to 80 years

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) regularly performing descent activities (stairs/ramps) * Age ≥ 18 years * Willing and able to participate in the study and follow the protocol 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 Navii 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

Contacts and locations

Locations

  • Össur Orlando

    Orlando, Florida, 32819, United States

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