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New knee brace could ease pain without surgery

NCT ID NCT05428332

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a special knee brace, called a Tri-Compartment Unloader, can reduce pain and improve function in people with anterior knee pain. Twenty adults with knee pain that worsens when bending and bearing weight wore the brace during physical therapy and daily activities. Researchers measured pain and function using questionnaires to see if the brace helped more than standard care alone.

What this could mean

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

Active substance
Tri-Compartment Unloader knee brace
What this could lead to
If it works, this brace could offer a non-surgical way to ease knee pain and improve daily function for people with anterior knee pain.
What could go wrong
This is a small, early study with only 20 participants, so results may not apply to everyone. The brace may not help all types of knee pain.

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

20 people

The number who actually took part.

Started

Apr 2022

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Accepted

You do not need to have the condition being studied to take part.

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: 1. Anterior knee pain that worsens when the knee is flexed and bearing weight 2. Patellofemoral chondral defect(s) or patellofemoral arthritis detected with standard of care x-ray and/or MRI 3. Kellgren and Lawrence grade 0-3 of PF joint 4. Able to wear the TCU knee brace for a minimum of 3 hours per day 5. Over 18 years old, can understand written English 6. Coronal knee alignment within 7 degrees of neutral 7. Must be able to fit within an off-the-shelf knee brace size provided by Company 8. Must complete physical therapy through Stanford Exclusion Criteria: 1. Surgical intervention definitely indicated (major mechanical symptoms/failed substantial previous conservative measures) on the affected knee within the next year 2. Use of another brace designed to unload the knee or manage knee pain during the study 3. Varus/Valgus joint alignment \> 7 degrees 4. Inability to be fit properly in an off-the-shelf brace provided by the Company 5. BMI \>40 6. Bilateral knee symptoms

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Stanford Redwood City Outpatient Center

    Redwood City, California, 94063, United States

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