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

NCT05997381 | Recruiting FDA Device

• 1 other identifier: CSP-BB0003
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rotator cuff tear; Full thickness tear; BioBrace

Outcome Measures

Primary Outcomes (1)

• 6 Month Retear Rate

  The between-group difference in radiological incidence (MRI) of a Sugaya Type IV or V full-thickness discontinuity at postoperative Month 6.

  6 months post-op

Secondary Outcomes (4)

• 12 Month Retear Rate

  12 months post-op

• Single Assessment Numeric Evaluation (SANE)

  Baseline, 6 weeks, 3-, 6-, and 12-months post-op

• Western Ontario Rotator Cuff Index (WORC)

  Baseline, 6 weeks, 3-, 6-, and 12-months post-op

• EuroQOL Five Dimensions Questionnaire (EQ-5D-5L)

  Baseline, 6 weeks, 3-, 6-, and 12-months post-op

Study Arms (2)

BioBrace Augment Group

EXPERIMENTAL

An arthroscopic rotator cuff repair is performed with the BioBrace Implant fixed on top of the repaired tendon using anchors.

Device: Arthroscopic rotator cuff repair with BioBrace® Implant augmentation.

Repair Only Group

SHAM COMPARATOR

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

Procedure: Arthroscopic rotator cuff repair

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.

BioBrace Augment Group

Arthroscopic rotator cuff repair PROCEDURE

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

Repair Only Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 40 to 70 years old
• Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder indicating a full thickness rotator cuff tear (RCT):
• Tear of the supraspinatus and/or infraspinatus tendons
• Tear size ≥ 2 cm and \< 5 cm
• Chronic shoulder pain ≥ 3 months
• Failed non-operative treatment of the index shoulder to include one or all of the following:
• Oral analgesics
• Nonsteroidal anti-inflammatory medications (NSAIDs)
• Corticosteroid injections
• Activity modifications
• Physical therapy or home-guided exercises
• Able to read and understand the study REB/IRB approved Informed Consent Form (ICF)
• Willing to be available to attend each protocol-required follow-up examination
• Full thickness tear of the supraspinatus and/or infraspinatus tendons
• Tear size ≥ 2 cm and \< 5 cm

You may not qualify if:

• Previous surgery of the index shoulder one year prior to the study surgery excluding diagnostic arthroscopy
• Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 (Goutallier Score)
• Major medical condition that could affect quality of life and influence the results of the study as determined by the Investigator
• Oral steroid use or steroid injection within 6 weeks prior to surgery
• Active smoker
• History of insulin-dependent diabetes
• Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
• Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)
• Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder
• History of claustrophobia that would prevent an MRI of the index shoulder
• Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study
• Currently participating, or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator
• History of non-compliance with medical treatment or clinical trial participation
• The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant with protocol required follow-up
• Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator

Sponsors & Collaborators

• CONMED Corporation: lead

Study Sites (1)

ConMed

New Haven, Connecticut, 06513, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Kelley Grynewicz

CONTACT

727-457-4955; BioBraceRCT@ConMed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: January 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-06

Locations

US (1)