Using a bioinductive graft to treat large rotator cuff tears
Official title: A Prospective, Randomized Evaluation of Bioinductive Augmentation for High Risk Rotator Cuff Tears
Run by Nova Scotia Health Authority · NCT04248751 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new type of graft to see if it can help people with large rotator cuff tears heal better and reduce the chances of needing more surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT04248751 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with MRI-confirmed large rotator cuff tears resulting from trauma or degeneration.
✕Probably not a fit
Patients with specific shoulder conditions, such as subscapular tears or glenohumeral osteoarthritis, will 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 evaluates the effectiveness of a bioinductive graft in treating large rotator cuff tears greater than 3 cm, which are often difficult to repair surgically. Patients with confirmed large rotator cuff tears will undergo surgical intervention involving debridement and the application of the graft. The goal is to improve healing rates and reduce the high re-tear rates associated with traditional surgical techniques. The study will assess patient outcomes in terms of pain relief and functional improvement post-surgery.
Why it matters
Potential benefit: If successful, this approach could significantly enhance healing rates and reduce the likelihood of re-tears in patients with large rotator cuff injuries.
How similar studies have gone: While there have been various surgical techniques for rotator cuff repair, the use of bioinductive grafts is a relatively novel approach that has not been extensively tested in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Magnetic resonance imaging (MRI) proven diagnosis of a large \>3cm tear of the shoulder rotator cuff in a competent adult (\>18 years of age). Exclusion Criteria: * Patients with subscapular tear * Glenohumeral osteoarthritis * A normalized WORC score \>70 (where scores range between 0-100, and 100 is the best outcome) * Uncontrolled diabetes (Hgb A1C \>7%) * Pregnancy * Presence of local or systemic infection * Inability to cooperate with and/or comprehend post-operative instructions * Nonvascular surgical sites (MRI proven) * Poor nutritional state (Alb \<30 g/L) * Cancer * Paralysis of the shoulder * Contracture of the shoulder * Presence of cuff tear arthropathy or osteoarthritis 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 — Orthopaedic Surgeon
- Study coordinator: Sara Sparavalo, MASc
- Email: sara@drivanwong.com
- Phone: 9024734251
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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.