Maximal Repair Versus Bridging Reconstruction with BioBrace®

Nova Scotia Health Authority (NSHA)

Status: Enrolling

Conditions: Bioinductive Implant; Rotator Cuff Tears

Treatments: Procedure: Bridging Reconstruction using BioBrace; Procedure: Repair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05959733

BioBridge

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Repair

Active Comparator group

Description:

This group will undergo a rotator cuff repair procedure.

Treatment:

Procedure: Repair

Bridging Reconstruction using BioBrace

Experimental group

Description:

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

Treatment:

Procedure: Bridging Reconstruction using BioBrace