Maximal Repair Versus Bridging Reconstruction with BioBrace®

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority

About this trial

The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.

Eligibility criteria

Qualifiers

magnetic resonance imaging (MRI) proven diagnosis of a large or massive (> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff

over 18 years of age

Disqualifiers

glenohumeral osteoarthritis

Western Ontario rotator cuff score >60

uncontrolled diabetes (Hgb A1C >7%)

pregnant

Trial design

Treatments tested in this trial

  • Bridging Reconstruction using BioBrace
  • Repair

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nova Scotia Health Authority

Lead sponsor

CONMED Corporation

Collaborator