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New BioBrace scaffold aims to boost shoulder surgery healing

NCT ID NCT05487677

Disease control Sponsor: Stanford University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study tests whether adding a special scaffold called BioBrace to the standard stitch repair of a shoulder muscle (subscapularis) during total shoulder replacement leads to better healing. About 100 adults getting shoulder replacement will be randomly assigned to receive either the standard repair or the repair reinforced with the BioBrace. The main goal is to compare ultrasound images of the muscle healing, and also to see if there are any differences in shoulder function or pain.

What this could mean

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

Active substance
BioBrace scaffold (a biocomposite implant used to reinforce the repaired rotator cuff muscle during shoulder replacement surgery)
What this could lead to
If it works, this could lead to a stronger, more reliable repair of the shoulder muscle after replacement, potentially improving healing and reducing the chance of re-tear.
What could go wrong
This is a small, early-stage trial focused on imaging outcomes, not yet proven to improve patient symptoms. The BioBrace is a new device, and its long-term safety and effectiveness are still unknown.

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 100 people

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

Started

Dec 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

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

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: * Total Shoulder Arthroplasty Exclusion Criteria: * Vulnerable population

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Conditions

The condition(s) this trial relates to.

Shoulder Injuries

As listed by the trial registrant

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

Shoulder injuries

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

  • Stanford University

    RECRUITING

    Redwood City, California, 94063, United States

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