Actively Recruiting
REinForce: A Prospective, Single Blind, Multi-Center, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the BioBrace® Implant During Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Led by CONMED Corporation · Updated on 2026-04-23
268
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the treatment of full-thickness rotator cuff tears involving the supraspinatus and/or infraspinatus tendons measuring between 2 and 5 cm. It aims to compare the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant against the standard arthroscopic rotator cuff repair alone. The study is prospective, single-blind, multi-center, randomized, and controlled, focusing on subjects needing surgical repair for these specific tears. Participants will be randomly assigned to one of two groups: one undergoing arthroscopic rotator cuff repair with the BioBrace® Implant fixed over the repaired tendon using anchors, and the other receiving the standard arthroscopic rotator cuff repair alone. The BioBrace® Implant is a bioresorbable, biocomposite scaffold designed to reinforce weakened soft tissue, composed of a collagen sponge and poly-L-lactic-acid (PLLA). Treatments follow standard surgical procedures, and the study includes preoperative and postoperative evaluations. Participants will have clinical assessments at baseline before surgery, and then at 6 weeks, 3 months, 6 months, and 12 months after surgery. These evaluations include patient-reported outcome measures and MRI scans to assess the repair integrity and re-tear rates. The primary outcome is the re-tear rate at 6 months post-operation, with secondary outcomes measured at 12 months and patient function and quality of life assessed through standardized questionnaires. Follow-up visits ensure safety monitoring and comprehensive data collection over a year.
CONDITIONS
Brief 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 for at least 3 months
- Failed non-operative treatment including one or more of oral analgesics, NSAIDs, corticosteroid injections, activity modifications, or physical therapy
- Able to read and understand the informed consent form
- Willing to attend all required follow-up visits
- Intraoperative confirmation of full thickness tear with ability to reapproximate tendons covering more than 50% of the footprint
You will not qualify if you...
- Previous surgery on the affected shoulder within one year prior to study surgery, except 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 injection within 6 weeks prior to surgery
- Active smoker
- History of insulin-dependent diabetes
- History of drug or alcohol abuse within 12 months
- Allergies to implant materials such as collagen, PLLA, or PEG
- Presence of metallic implants preventing MRI evaluation
- Claustrophobia preventing MRI
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Participation in another clinical trial affecting study outcomes
- History of non-compliance with medical treatment or trials
- Physical or mental conditions preventing compliance
- Poor surgical candidate due to comorbidities
- Use of prescription narcotic pain medication
- Current infection near the surgical site
- Contralateral shoulder condition requiring rotator cuff repair
- Worker's compensation cases
- Need for subscapularis repair other than single anchor repair intraoperatively
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo arthroscopic rotator cuff repair surgery, either with the BioBrace® Implant augmentation or standard repair alone.
1 surgical visit (in-person)
Duration - 12 months
Participants are evaluated post-operatively to monitor recovery, repair integrity, and re-tear rate using clinical evaluations and MRI.
Visits at 6 weeks, 3 months, 6 months, and 12 months post-operatively (in-person)
Trial Site Locations
Total: 1 location
1
ConMed
New Haven, Connecticut, United States, 06513
Actively Recruiting
Research Team
K
Kelley Grynewicz
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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