Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement

Study Overview
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Brief Summary
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Randomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair.

Detailed Description
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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).

Official Title
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Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement: A Prospective Randomized Double Blind Controlled Trial

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Procedure: Coblation Debridement (FLOW90)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Paralle study arms for 1)coblation debridement, 2) mechanical debridement
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coblation Debridement<br>FLOW 90 / WEREWOLF debridement of rotator cuff footprint. | Procedure: Coblation Debridement (FLOW90)<br>* bipolar radiofrequency energy<br>|
| Active Comparator: Mechanical Debridement<br>Standard mechanical debridement of rotator cuff footprint. | Procedure: Coblation Debridement (FLOW90)<br>* bipolar radiofrequency energy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Rotator Cuff Score (WORC) | Shoulder based quality of life measurement tool | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Rotator Cuff Score (WORC) | Shoulder based quality of life measurement tool | 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 | 3 months, 6 months, 12 months, 24 months | 
| Re-tear of rotator cuff | Evaluated via MRI | 12 months |