Clinical trial NCT05084781: Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement
Official title: Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement: A Prospective Randomized Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Paralle study arms for 1)coblation debridement, 2) mechanical debridement
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario Rotator Cuff Score (WORC)
timeFrame: 24 months
Secondary outcomes:
measure: Western Ontario Rotator Cuff Score (WORC)
timeFrame: 3 months, 6 months, 12 months
measure: Quick Disability of the Arm Shoulder and Hand (QuickDASH) questionnaire
timeFrame: 3 months, 6 months, 12 months, 24 months
measure: Re-tear of rotator cuff
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Access Orthopaedics
state: Alberta
Study officials:
affiliation: University of Calgary
name: Ian Lo, MD FRSCS
role: PRINCIPAL_INVESTIGATOR
References: