Randomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
bipolar radiofrequency energy
Access Orthopaedics
Calgary, Alberta, Canada
RECRUITINGWestern Ontario Rotator Cuff Score (WORC)
Shoulder based quality of life measurement tool
Time frame: 24 months
Western Ontario Rotator Cuff Score (WORC)
Shoulder based quality of life measurement tool
Time frame: 3 months, 6 months, 12 months
Quick Disability of the Arm Shoulder and Hand (QuickDASH) questionnaire
Short version of the DASH questionnaire for musculoskeletal disorders of the upper extremity
Time frame: 3 months, 6 months, 12 months, 24 months
Re-tear of rotator cuff
Evaluated via MRI
Time frame: 12 months
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