Comparing two methods for repairing rotator cuff tears
Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement: A Prospective Randomized Double Blind Controlled Trial
NA · University of Calgary · NCT05084781
This study is testing whether a new way to clean up tissue during rotator cuff surgery helps patients recover better than the traditional method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary (other) |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05084781 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial that compares the effectiveness of coblation debridement versus mechanical debridement in patients undergoing surgical repair for full thickness rotator cuff tears. Participants, aged 18 and older, will be randomly assigned to one of the two treatment groups after confirming their eligibility through pre-operative assessments. The study includes a standard post-operative rehabilitation program and follow-up evaluations at 3, 6, 12, and 24 months to assess recovery and outcomes. The goal is to determine which debridement method leads to better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a repairable full thickness rotator cuff tear who have not responded to conservative treatments for more than 3 months.
Not a fit: Patients with previous rotator cuff repair surgery, partial thickness tears, or irreparable tears will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients with rotator cuff tears.
How similar studies have performed: Previous studies have shown varying success with different debridement techniques, making this approach both relevant and necessary for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The subject has signed the REB approved informed consent form (ICF) specific to this study prior to enrollment 2. The subject has a repairable full thickness rotator cuff tear with an estimated full thickness size \<5cm confirmed with diagnostic MRI in AP or ML dimension and /or ultrasound 3. The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits 4. The subject has persistent pain and functional disability and has failed conservative treatment (e.g. PT, steroid injection, anti-inflammatory) for \> 3 months 5. The subject is at least eighteen (18) years of age and considered to be skeletally mature Exclusion Criteria: 1. The subject has undergone previous rotator cuff repair surgery to the affected shoulder 2. The subject has a partial thickness rotator cuff tear 3. The subject requires a concomitant labral repair 4. The subject has an irreparable rotator cuff tear 5. The subject is unable or unwilling to undergo MRI scan. 6. The investigator judges the subject unlikely to remain compliant to follow-up. 7. The subject has received an investigational therapy or approved therapy for investigational use within 30 days prior to the surgery 8. The subject is a prisoner, or is known or suspected to be transient 9. The subject's condition represents a worker's compensation case 10. The subject is currently involved in a health-related litigation procedure 11. The subject currently has an acute infection in the area surrounding the surgical site 12. The subject has a major medical illness (life expectancy less than 2 years or unacceptably high operative risk 13. Fatty atrophy \>50% (Goutallier grade 4-5) INTRA-OPERATIVE EXCLUSIONS: 1. Massive or irreparable rotator cuff tear which cannot be mobilized to the midpoint of the footprint of the rotator cuff on the greater tuberosity 2. Co-existing labral pathology requiring repair with sutures
Where this trial is running
Calgary, Alberta
- Access Orthopaedics — Calgary, Alberta, Canada (RECRUITING)
Study contacts
- Principal investigator: Ian Lo, MD FRSCS — University of Calgary
- Study coordinator: Ian Lo, MD FRCSC
- Email: ikylo@ucalgary.ca
- Phone: 403-284-4062
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.
Conditions: Rotator Cuff Tears