Maximal Repair Versus Bridging Reconstruction with BioBrace®

Recruiting now · Not applicable

Conditions studied: Rotator Cuff Tears, Bioinductive Implant

In brief

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.

Key facts

Study ID

NCT05959733

Run by

Nova Scotia Health Authority

People needed

60

Starts

2023-12-07

Expected to finish

2027-07-31

Last updated by the study team

2025-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• glenohumeral osteoarthritis
• Western Ontario rotator cuff score >60
• uncontrolled diabetes (Hgb A1C >7%)
• pregnant
• local or systemic infection
• inability to cooperate with and/or comprehend post-operative instructions
• MRI proven non-vascular sites
• poor nutritional state (Alb <30 g/L)
• cancer
• paralysis of the shoulder
• contracture of the shoulder
• patients unable to provide informed consent for the study

Where it is running

• Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (enrolling)

Full record on ClinicalTrials.gov

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