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Maximal Repair Versus Bridging Reconstruction with BioBrace®

RecruitingNAAges 18 Years - anyAllNova Scotia Health Authority
NCT05959733 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Bridging Reconstruction using BioBrace
  • Repair
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Where

1 site
Nova Scotia Health Authority
Halifax, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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