Maximal Repair Versus Bridging Reconstruction with BioBrace®

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 7, 2023

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2027

Conditions
Rotator Cuff TearsBioinductive Implant
Interventions
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.

Trial Locations (1)

B3H2E1

RECRUITING

Nova Scotia Health Authority, Halifax

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CONMED Corporation

INDUSTRY

lead

Nova Scotia Health Authority

OTHER

NCT05959733 - Maximal Repair Versus Bridging Reconstruction with BioBrace® | Biotech Hunter | Biotech Hunter