Arthroscopic rotator cuff repair with BioBrace® implant

REinForce: A Prospective, Single Blind, Multi-Center, Randomized, Controlled, Pivotal Study to Evaluate the Safety and Effectiveness of the BioBrace® Implant During Arthroscopic Repair of Full Thickness Rotator Cuff Tears

This study will test whether adding the BioBrace® implant to arthroscopic rotator cuff repair improves healing and reduces re-tear in adults 40–70 with full-thickness supraspinatus or infraspinatus tears measuring 2–5 cm.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 268 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: CONMED Corporation (Industry-sponsored)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT05997381 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-blind, multi-center, randomized, controlled pivotal study comparing arthroscopic rotator cuff repair augmented with the BioBrace® implant versus repair alone for full-thickness supraspinatus and/or infraspinatus tears sized 2–5 cm. Eligible subjects undergo baseline assessment and are randomized to receive standard arthroscopic repair with or without BioBrace augmentation. Follow-up visits occur at 6 weeks and 3, 6, and 12 months with patient-reported outcome measures and MRI to assess repair integrity and re-tear rates. Intraoperative confirmation is required that the tendon can be reapproximated to cover more than 50% of the footprint.

Who should consider this trial

Good fit: Ideal candidates are adults 40–70 years old with chronic full-thickness supraspinatus and/or infraspinatus tears 2–5 cm in size who have failed nonoperative care and whose tendon can be reapproximated to cover >50% of the footprint.

Not a fit: Patients with tears smaller than 2 cm or larger than 5 cm, those who cannot have the tendon reapproximated over >50% of the footprint, acute injuries, or persons outside the 40–70 age range may not benefit or be eligible.

Why it matters

Potential benefit: If successful, BioBrace augmentation could improve tendon healing, lower re-tear rates, and speed functional recovery after rotator cuff repair.

How similar studies have performed: Other smaller studies of biologic or scaffold augmentation for rotator cuff repair have shown mixed but sometimes promising results, while large randomized pivotal data remain limited.

Eligibility criteria

Inclusion Criteria:

1. Male or female 40 to 70 years old
2. Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder indicating a full thickness rotator cuff tear (RCT):

   1. Tear of the supraspinatus and/or infraspinatus tendons
   2. Tear size ≥ 2 cm and \< 5 cm
3. Chronic shoulder pain ≥ 3 months
4. Failed non-operative treatment of the index shoulder to include one or all of the following:

   1. Oral analgesics
   2. Nonsteroidal anti-inflammatory medications (NSAIDs)
   3. Corticosteroid injections
   4. Activity modifications
   5. Physical therapy or home-guided exercises
5. Able to read and understand the study REB/IRB approved Informed Consent Form (ICF)
6. Willing to be available to attend each protocol-required follow-up examination

Intraoperative Inclusion Criteria:

1. Full thickness tear of the supraspinatus and/or infraspinatus tendons
2. Tear size ≥ 2 cm and \< 5 cm
3. Able to reapproximate the tendons to cover \> 50% of the footprint on the greater tuberosity

Exclusion Criteria:

1. Previous surgery of the index shoulder one year prior to the study surgery excluding diagnostic arthroscopy
2. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 (Goutallier Score)
3. Major medical condition that could affect quality of life and influence the results of the study as determined by the Investigator
4. Oral steroid use or steroid injection within 6 weeks prior to surgery
5. Active smoker
6. History of insulin-dependent diabetes
7. Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
8. Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)
9. Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder
10. History of claustrophobia that would prevent an MRI of the index shoulder
11. Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study
12. 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
13. History of non-compliance with medical treatment or clinical trial participation
14. 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
15. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator
16. The subject is receiving prescription narcotic pain medication
17. The subject currently has an acute infection in the area surrounding the surgical site
18. Contralateral shoulder condition where rotator cuff repair is scheduled or to be scheduled over the course of this study
19. The subject's condition represents a worker's compensation case

Intraoperative Exclusion Criteria:

1\. Subject requires subscapularis repair other than a repair with a single anchor

Where this trial is running

New Haven, Connecticut

• ConMed — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Study coordinator: Kelley Grynewicz

Conditions Rotator Cuff Tears; Rotator cuff tear; Full thickness tear; BioBrace