Rotator Cuff Tears
Conditions
Brief summary
Randomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair.
Detailed description
Prospective, Double blind, Randomized controlled trial. Male and female subjects, over the age of 18 years. Full thickness rotator cuff tear, requiring surgical repair. Patient undergoes pre- and intra-operative assessment, and once eligibility is confirmed intra-operatively, patient is randomly assigned to receive either a) coblation debridment, or b) mechanical debridement. Standard post-operative rehab program for all patients. Follow-up occurs at 3, 6, 12, and 24 months post operatively and includes physical exam and patient based outcomes (questionnaires).
Interventions
PROCEDURECoblation Debridement (FLOW90)
bipolar radiofrequency energy
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double blind - patient and outcome assessor.
Intervention model description
Paralle study arms for 1)coblation debridement, 2) mechanical debridement
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Rotator Cuff Score (WORC) | 24 months | Shoulder based quality of life measurement tool |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Rotator Cuff Score (WORC) | 3 months, 6 months, 12 months | Shoulder based quality of life measurement tool |
| Quick Disability of the Arm Shoulder and Hand (QuickDASH) questionnaire | 3 months, 6 months, 12 months, 24 months | Short version of the DASH questionnaire for musculoskeletal disorders of the upper extremity |
| Re-tear of rotator cuff | 12 months | Evaluated via MRI |
Countries
Canada
Contacts
Primary ContactIan Lo, MD FRCSC
Backup ContactKristie More, MSc
Outcome results
None listed