BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears (CSP-BB0003)

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 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.

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 supraspinatus and/or infraspinatus tendons and measure ≥ 2 cm and < 5 cm. Subjects meeting the inclusion/exclusion criteria will be enrolled and will undergo either arthroscopic rotator cuff repair augmented with the BioBrace® Implant or arthroscopic rotator cuff repair alone. Clinical evaluations will be conducted at baseline (pre-operatively) and at 6 weeks, 3-, 6-, and 12-months post-operatively using various patient-reported outcome measures and MRI to assess repair integrity and re-tear rate.

Accepting Participants

Treatment

Orthopaedic

Learn More

To learn more, visit ClinicalTrials.Gov or contact Clinical Research at 864-560-6812.

Principal Investigator(s)

Gregory Colbath, MD

Sponsor(s)

CONMED Coorporation

Key Trial Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
- 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 Inclusion Criteria:
- 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
A patient will not be eligible for participation in this study if any of the following criteria apply.
- 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 Exclusion Criteria:
- Subject requires subscapularis repair other than a repair with a single anchor

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