New scaffold aims to stop rotator cuff repairs from failing

NCT ID NCT05997381

Recruiting now Disease control Sponsor: CONMED Corporation Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a BioBrace® implant during rotator cuff surgery helps the tendon heal better and reduces the chance of re-tearing. About 268 adults aged 40–70 with full-thickness tears will be randomly assigned to get surgery with or without the implant. The main goal is to see if the implant lowers the retear rate at 6 months, as seen on MRI.

What this could mean

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

Active substance: BioBrace® implant (a bioresorbable scaffold that reinforces the repaired tendon)
What this could lead to: If it works, this implant could lower the chance of the rotator cuff tearing again after surgery, helping people recover more fully.
What could go wrong: This is a mid-stage trial, so results are not yet proven. The implant may not reduce retear rates and could carry surgical risks like infection or poor healing.

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

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

ROTATOR CUFF TEARS

Contacts and locations

Locations

ConMed
RECRUITING

New Haven, Connecticut, 06513, United States

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