NCT05959733

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Tears
• Bioinductive Implant

Interventions

Type	Name	Description
PROCEDURE	Bridging 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.
PROCEDURE	Repair	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.

Timeline

• Start date: 2023-12-07
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2023-07-25
• Last updated: 2025-02-18

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study