Actively Recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Led by CONMED Corporation · Updated on 2026-04-23
268
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 40 to 70 years
- Full thickness rotator cuff tear of the supraspinatus and/or infraspinatus tendons confirmed by MRI within 6 months
- Tear size between 2 cm and less than 5 cm
- Chronic shoulder pain lasting 3 months or longer
- Failed non-operative treatments including oral analgesics, NSAIDs, corticosteroid injections, activity modifications, or physical therapy
- Able to understand and consent to the study
- Willing to attend all required follow-up visits
- Intraoperative criteria: ability to reapproximate tendons to cover more than 50% of the footprint on the greater tuberosity
You will not qualify if you...
- Previous surgery on the index shoulder within 1 year prior to study surgery excluding diagnostic arthroscopy
- Fatty infiltration of the rotator cuff muscle grade 3 or higher
- Major medical conditions affecting quality of life or study results
- Oral steroid use or steroid injections within 6 weeks prior to surgery
- Active smoking
- History of insulin-dependent diabetes
- History of drug or alcohol abuse within 12 months
- Hypersensitivity to implant materials such as collagen from bovine origin, PLLA, or PEG
- Presence of metallic implants preventing MRI review
- Claustrophobia preventing MRI
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Participation in another clinical trial that affects study outcomes
- History of non-compliance with medical treatment or clinical trials
- Physical or mental conditions impairing compliance
- Any comorbidity making the patient a poor surgical candidate
- Use of prescription narcotic pain medication
- Acute infection near the surgical site
- Scheduled or planned rotator cuff repair on the opposite shoulder
- Worker's compensation cases
- Intraoperative exclusion: need for subscapularis repair other than with a single anchor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
ConMed
New Haven, Connecticut, United States, 06513
Actively Recruiting
Research Team
K
Kelley Grynewicz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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