Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement

NCT05084781 | Unknown FDA Device

• 1 other identifier: REB19-1158
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Western Ontario Rotator Cuff Score (WORC)

  Shoulder based quality of life measurement tool

  24 months

Secondary Outcomes (3)

• Western Ontario Rotator Cuff Score (WORC)

  3 months, 6 months, 12 months

• Quick Disability of the Arm Shoulder and Hand (QuickDASH) questionnaire

  3 months, 6 months, 12 months, 24 months

• Re-tear of rotator cuff

  12 months

Study Arms (2)

Coblation Debridement

EXPERIMENTAL

FLOW 90 / WEREWOLF debridement of rotator cuff footprint.

Procedure: Coblation Debridement (FLOW90)

Mechanical Debridement

ACTIVE COMPARATOR

Standard mechanical debridement of rotator cuff footprint.

Procedure: Coblation Debridement (FLOW90)

Interventions

Coblation Debridement (FLOW90) PROCEDURE

bipolar radiofrequency energy

Coblation Debridement; Mechanical Debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Access Orthopaedics

Calgary, Alberta, T2R2G5, Canada

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Ian Lo, MD FRSCS

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Lo, MD FRCSC

CONTACT

403-284-4062; ikylo@ucalgary.ca

Kristie More, MSc

CONTACT

403-284-4062; kristie.more@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind - patient and outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Paralle study arms for 1)coblation debridement, 2) mechanical debridement

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 20, 2021
• Study Start: July 8, 2020
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)