Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement
Rotator Cuff TearsRandomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation 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
Study Location
Access Orthopaedics
Access OrthopaedicsCalgary, Alberta
Canada
Contact Study Team
- Study Sponsored By
- University of Calgary
- Participants Required
- More Information
- Study ID:
NCT05084781