BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears

Launched by CONMED CORPORATION · Aug 10, 2023

Keywords

ClinConnect Summary

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 ...

Gender

ALL

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