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BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears

NCT05997381 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2026-04-23

No results posted yet for this study

Summary

This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.

Conditions

  • Rotator Cuff Tears

Interventions

DEVICE

Arthroscopic rotator cuff repair with BioBrace® Implant augmentation.

An arthroscopic rotator cuff repair will be performed and augmented with the BioBrace® Implant. The BioBrace® Implant is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA). When used in rotator cuff repairs, it is placed on top of the tendons to augment and reinforce the underlying repair. The BioBrace® is designed to mechanically and biologically augment weakened or torn soft tissue and can be integrated into surgeons' standard of care rotator cuff repair techniques.

PROCEDURE

Arthroscopic rotator cuff repair

An arthroscopic rotator cuff repair is performed using standard surgical procedure.

Sponsors & Collaborators

  • CONMED Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-05
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05997381 on ClinicalTrials.gov