A Prospective, Randomized Evaluation of Bioinductive Augmentation for High-Risk Rotator Cuff Tears
Eligibility
Inclusion Criteria:
The inclusion criterion for the present study is a magnetic resonance imaging (MRI) proven diagnosis of a large, repairable rotator cuff tear involving supraspinatus and infraspinatus tendons in a competent adult (>18).
Exclusion Criteria:
The exclusion criteria for the present study are patients with irreparable subscapularis tears; pre-operative WORC score of <30; shoulder instability; presence of OA; uncontrolled diabetes; pregnancy; cancer or other severe illnesses.
Contact
- iv@drivanwong.com, 902-473-2114, Ivan.Wong@nshealth.ca
PI
Dr. Ivan Wong
Description
This randomized, controlled trial is comparing arthroscopic maximal repair to repair with Regeneten augmentation for large rotator cuff tears. MRI healing/re-tear rate will be used as the primary determinant of outcomes. The Western Ontario Rotator Cuff (WORC) Index will be administered at two-years post-op, along with assessing patients’ ROM, strength, Disabilities Arm Shoulder and Hand (DASH) questionnaire, safety, and CT outcomes as secondary determinants of outcomes.
Sample size = 106