BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
ConditionRotator Cuff Tears
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorCONMED Corporation
About this trial
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.
Eligibility criteria
Qualifiers
Male or female 40 to 70 years old
Tear of the supraspinatus and/or infraspinatus tendons
Tear size ≥ 2 cm and < 5 cm
Chronic shoulder pain ≥ 3 months
Disqualifiers
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
Trial design
Treatments tested in this trial
- Arthroscopic rotator cuff repair with BioBrace® Implant augmentation.
- Arthroscopic rotator cuff repair
Treatment groups
268 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov