New BioBrace scaffold aims to boost shoulder surgery healing

NCT ID NCT05487677

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

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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.

Contacts and locations

Locations

  • Stanford University

    RECRUITING

    Redwood City, California, 94063, United States

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Other studies related to the condition(s) this trial covers.