Status:
RECRUITING
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Lead Sponsor:
CONMED Corporation
Conditions:
Rotator Cuff Tears
Eligibility:
All Genders
40-70 years
Phase:
NA
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 surgi...
Detailed Description
This is a prospective, single blind, multi-center, randomized, controlled, pivotal clinical study investigating the treatment of full thickness tears of the rotator cuff. Tears must involve the supras...
Eligibility Criteria
Inclusion
- 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
- Intraoperative
- Full thickness tear of the supraspinatus and/or infraspinatus tendons
- Tear size ≥ 2 cm and \< 5 cm
- Able to reapproximate the tendons to cover \> 50% of the footprint on the greater tuberosity
Exclusion
- 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
- The subject is receiving prescription narcotic pain medication
- The subject currently has an acute infection in the area surrounding the surgical site
- Contralateral shoulder condition where rotator cuff repair is scheduled or to be scheduled over the course of this study
- The subject's condition represents a worker's compensation case
- Intraoperative
Key Trial Info
Start Date :
January 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT05997381
Start Date
January 5 2024
End Date
June 1 2027
Last Update
September 17 2025
Active Locations (1)
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1
ConMed
New Haven, Connecticut, United States, 06513