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Maximal Repair Versus Bridging Reconstruction with BioBrace®

Rotator Cuff Tears | Bioinductive Implant

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Study Location

Nova Scotia Health Authority
Nova Scotia Health Authority
Halifax, Nova Scotia
Canada

Contact Study Team

Primary Contact

Ivan Wong

[email protected]
9024737626
Study Sponsored By
Nova Scotia Health Authority
Participants Required
More Information
Study ID: NCT05959733