Recruiting

Maximal Repair & Bridging Reconstruction

Sponsor:

Nova Scotia Health Authority

Code:

NCT05959733

Conditions

Rotator Cuff Tears

Bioinductive Implant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bridging Reconstruction using BioBrace

Repair

Study Details

Brief 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

Study ID

NCT05959733

Start date

Dec 7, 2023

Status verified date

Feb, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Repair

This group will undergo a rotator cuff repair procedure.

experimental: Bridging Reconstruction using BioBrace

This experimental group will undergo bridging reconstruction using the bioinductive implant, BioBrace.

Interventions

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.

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.

Primary outcome measure

  • Radiographic or clinical failure [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Sarah Remedios, MSc

9024737626research@drivanwong.com

Locations

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3H2E1

Contacts

Ivan Wong

9024737626research@drivanwong.com

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Feb 18, 2025

Last verified

Feb, 2025

Keywords

  • shoulder
  • rotator cuff
  • clinical outcomes
  • radiographic outcomes
  • biomechanics
  • bridging reconstruction
  • rotator cuff repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2025-02-18.