Maximal Repair Versus Bridging Reconstruction with BioBrace®

Sponsor
Nova Scotia Health Authority
Study ID
NCT05959733
Status
Recruiting
Apply to this trial

Conditions

  • Bioinductive Implant
  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bridging Reconstruction using BioBrace — PROCEDURE
    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 — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Jul 25, 2023
Start date
Dec 7, 2023
Status verified
Feb 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Radiographic or clinical failure [ Time Frame: 2 years ]

Central Contacts

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