Comparing two methods for repairing rotator cuff tears using BioBrace®
Official title: Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis
Run by Nova Scotia Health Authority · NCT05959733 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Status | Recruiting |
| Started | December 7, 2023 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | February 18, 2025 |
| Trial ID | NCT05959733 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with MRI-confirmed large or massive rotator cuff tears involving the supraspinatus and infraspinatus tendons.
✕Probably not a fit
Patients with glenohumeral osteoarthritis, uncontrolled diabetes, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Rotator cuff repair with biceps rerouting and dermal graft augmentation for large, difficult tears
This study tests a combined surgical approach to see if it helps tendon retear rates in adults with large rotator cuff tears that are hard to repair.
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Biomarkers to see if rotator cuff repairs will heal after surgery
This study tests whether biomarkers in shoulder tissue and synovial fluid can predict whether a rotator cuff repair will heal, using MRI after surgery to compare those who heal with those who don’t.
-
Open Broström repair with BioBrace augmentation for chronic ankle instability
This study tests whether adding the BioBrace implant to a standard Broström repair improves outcomes for adults with chronic lateral ankle instability.
-
Mobilization with Movement for people with rotator cuff lesions
This trial will test whether Mobilization with Movement helps reduce pain, improve shoulder function, and restore joint position sense in adults with rotator cuff lesions.
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Does age-related muscle loss change rotator cuff tear patterns?
We will see if age-related muscle loss (sarcopenia) is linked to the location and type of rotator cuff tears in adults aged 40–75 with rotator cuff syndrome.
-
Impact of neck nerve compression (cervical radiculopathy) on recovery after rotator cuff repair
This study sees if people under 65 who had cervical radiculopathy before rotator cuff repair have different shoulder function and quality of life after surgery compared with those who did not.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.