RecruitingNot ApplicableNCT05959733

Maximal Repair Versus Bridging Reconstruction with BioBrace®

Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis

Sponsor

Nova Scotia Health Authority

Enrollment

60 participants

Start Date

Dec 7, 2023

Study Type

INTERVENTIONAL

Conditions

Rotator Cuff Tears Bioinductive Implant

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria12

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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Interventions

PROCEDUREBridging Reconstruction using BioBrace

Patients in the reconstruction group will undergo maximal repair with interposition bridging using BioBrace. This technique will follow a previously described technique by the principal investigator with differences allocated to the graft, it's preparation and insertion. The bursa will be debrided, and rotator cuff edged will be shaved down to stable tissue. BioBrace is bioinductive scaffold composed of highly porous type I collagen and bio-resorbable poly (L-lactide) (PLLA) microfilaments, and will be used as the graft in this trial.

PROCEDURERepair

Patients in the maximal repair group will undergo a SCOI-row rotator cuff repair with adequate tension as described previously, with recreation of the rotator cable. Briefly, the SCOI-row rotator cuff repair uses one triple loaded suture anchor for each 1.2cm of torn tendon. This technique has been completed in a previous randomized controlled trial.