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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
CONMED Corporation
Study ID
NCT05997381
Status
Recruiting
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Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Arthroscopic rotator cuff repair with BioBrace® Implant augmentation. — DEVICE
    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.
  • Arthroscopic rotator cuff repair — PROCEDURE
    An arthroscopic rotator cuff repair is performed using standard surgical procedure.

Study Details

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.

Key Dates

Start date
Jan 5, 2024
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
268 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BioBrace Augment Group
    An arthroscopic rotator cuff repair is performed with the BioBrace Implant fixed on top of the repaired tendon using anchors.
  • Sham Comparator: Repair Only Group
    An arthroscopic rotator cuff repair is performed using standard surgical procedure.

Primary Outcome Measure

6 Month Retear Rate [ Time Frame: 6 months post-op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ConMedNew HavenConnecticut06513
Kelley Grynewicz
[email protected]

Find similar trials in New Haven, CT

By research site
ConMed· New Haven, CT

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