Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement
- Conditions
- Rotator Cuff Tears
- Interventions
- Procedure: Coblation Debridement (FLOW90)
- Registration Number
- NCT05084781
- Lead Sponsor
- University of Calgary
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 94
- The subject has signed the REB approved informed consent form (ICF) specific to this study prior to enrollment
- 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
- The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits
- The subject has persistent pain and functional disability and has failed conservative treatment (e.g. PT, steroid injection, anti-inflammatory) for > 3 months
- The subject is at least eighteen (18) years of age and considered to be skeletally mature
- The subject has undergone previous rotator cuff repair surgery to the affected shoulder
- The subject has a partial thickness rotator cuff tear
- The subject requires a concomitant labral repair
- The subject has an irreparable rotator cuff tear
- The subject is unable or unwilling to undergo MRI scan.
- The investigator judges the subject unlikely to remain compliant to follow-up.
- The subject has received an investigational therapy or approved therapy for investigational use within 30 days prior to the surgery
- The subject is a prisoner, or is known or suspected to be transient
- The subject's condition represents a worker's compensation case
- The subject is currently involved in a health-related litigation procedure
- The subject currently has an acute infection in the area surrounding the surgical site
- The subject has a major medical illness (life expectancy less than 2 years or unacceptably high operative risk
- Fatty atrophy >50% (Goutallier grade 4-5)
INTRA-OPERATIVE EXCLUSIONS:
- Massive or irreparable rotator cuff tear which cannot be mobilized to the midpoint of the footprint of the rotator cuff on the greater tuberosity
- Co-existing labral pathology requiring repair with sutures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mechanical Debridement Coblation Debridement (FLOW90) Standard mechanical debridement of rotator cuff footprint. Coblation Debridement Coblation Debridement (FLOW90) FLOW 90 / WEREWOLF debridement of rotator cuff footprint.
- Primary Outcome Measures
Name Time Method Western Ontario Rotator Cuff Score (WORC) 24 months Shoulder based quality of life measurement tool
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Access Orthopaedics
🇨🇦Calgary, Alberta, Canada