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Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement (FLOW90)

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ClinicalTrials.gov Identifier: NCT05084781
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
University of Calgary

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

Condition or disease Intervention/treatment Phase
Rotator Cuff Tears Procedure: Coblation Debridement (FLOW90) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Paralle study arms for 1)coblation debridement, 2) mechanical debridement
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double blind - patient and outcome assessor.
Primary Purpose: Treatment
Official Title: Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement: A Prospective Randomized Double Blind Controlled Trial
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : June 30, 2025

Arm Intervention/treatment
Experimental: Coblation Debridement
FLOW 90 / WEREWOLF debridement of rotator cuff footprint.
Procedure: Coblation Debridement (FLOW90)
bipolar radiofrequency energy

Active Comparator: Mechanical Debridement
Standard mechanical debridement of rotator cuff footprint.
Procedure: Coblation Debridement (FLOW90)
bipolar radiofrequency energy




Primary Outcome Measures :
  1. Western Ontario Rotator Cuff Score (WORC) [ Time Frame: 24 months ]
    Shoulder based quality of life measurement tool


Secondary Outcome Measures :
  1. Western Ontario Rotator Cuff Score (WORC) [ Time Frame: 3 months, 6 months, 12 months ]
    Shoulder based quality of life measurement tool

  2. Quick Disability of the Arm Shoulder and Hand (QuickDASH) questionnaire [ Time Frame: 3 months, 6 months, 12 months, 24 months ]
    Short version of the DASH questionnaire for musculoskeletal disorders of the upper extremity

  3. Re-tear of rotator cuff [ Time Frame: 12 months ]
    Evaluated via MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05084781


Contacts
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Contact: Ian Lo, MD FRCSC 403-284-4062 ikylo@ucalgary.ca
Contact: Kristie More, MSc 403-284-4062 kristie.more@ucalgary.ca

Locations
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Canada, Alberta
Access Orthopaedics Recruiting
Calgary, Alberta, Canada, T2R2G5
Contact: Kristie More, MSc    403-284-4062    kristie.more@ucalgary.ca   
Contact: Deanne Meredyk    403-284-4062    shoulder@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Ian Lo, MD FRSCS University of Calgary
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT05084781    
Other Study ID Numbers: REB19-1158
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries