Comparing two methods for repairing rotator cuff tears using BioBrace®
Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis
This study is testing if using BioBrace® for repairing large rotator cuff tears helps patients recover better and feel stronger compared to traditional repair methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT05959733 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of using BioBrace® for bridging reconstruction in patients with large or massive rotator cuff tears compared to traditional maximal repair techniques. Researchers will assess various outcomes, including re-tear rates, patient-reported outcomes, shoulder strength, range of motion, muscle activation, and biomechanics through clinical evaluations and imaging techniques like x-ray and MRI. The goal is to determine if the BioBrace® method leads to improved recovery and functional outcomes for patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with MRI-confirmed large or massive rotator cuff tears involving the supraspinatus and infraspinatus tendons.
Not a fit: Patients with glenohumeral osteoarthritis, uncontrolled diabetes, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide patients with better recovery outcomes and reduced re-tear rates after rotator cuff surgery.
How similar studies have performed: While the use of bioinductive implants is a relatively novel approach, similar studies have shown promising results in improving surgical outcomes for rotator cuff repairs.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Halifax, Nova Scotia
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Principal investigator: Ivan Wong, MD — Nova Scotia Health Authority, Orthopaedic Surgeon
- Study coordinator: Sarah Remedios, MSc
- Email: research@drivanwong.com
- Phone: 9024737626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.