Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement
NCT ID: NCT05084781
Last Updated: 2021-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
94 participants
INTERVENTIONAL
2020-07-08
2025-06-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Coblation Debridement
FLOW 90 / WEREWOLF debridement of rotator cuff footprint.
Coblation Debridement (FLOW90)
bipolar radiofrequency energy
Mechanical Debridement
Standard mechanical debridement of rotator cuff footprint.
Coblation Debridement (FLOW90)
bipolar radiofrequency energy
Interventions
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Coblation Debridement (FLOW90)
bipolar radiofrequency energy
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Ian Lo, MD FRSCS
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Access Orthopaedics
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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REB19-1158
Identifier Type: -
Identifier Source: org_study_id