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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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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 and up

Critères de participation

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

Lieu de l'étude

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

Contactez l'équipe d'étude

Primary Contact

Ivan Wong

[email protected]
9024737626
Étude parrainée par
Nova Scotia Health Authority
Participants recherchés
Plus d'informations
ID de l'étude: NCT05959733