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

Primary Purpose

Rotator Cuff Tears

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Coblation Debridement (FLOW90)

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Access OrthopaedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coblation Debridement

Mechanical Debridement

Arm Description

FLOW 90 / WEREWOLF debridement of rotator cuff footprint.

Standard mechanical debridement of rotator cuff footprint.

Outcomes

Primary Outcome Measures

Western Ontario Rotator Cuff Score (WORC)

Shoulder based quality of life measurement tool

Secondary Outcome Measures

Western Ontario Rotator Cuff Score (WORC)

Shoulder based quality of life measurement tool

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

Short version of the DASH questionnaire for musculoskeletal disorders of the upper extremity

Re-tear of rotator cuff

Evaluated via MRI

Full Information

NCT ID

NCT05084781

First Posted

October 6, 2021

Last Updated

October 6, 2021

Sponsor

University of Calgary

1. Study Identification

Unique Protocol Identification Number

NCT05084781

Brief Title

Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement

Acronym

FLOW90

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 8, 2020 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tears

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Paralle study arms for 1)coblation debridement, 2) mechanical debridement

Masking

ParticipantOutcomes Assessor

Masking Description

Double blind - patient and outcome assessor.

Allocation

Randomized

Enrollment

94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Coblation Debridement

Arm Type

Experimental

Arm Description

FLOW 90 / WEREWOLF debridement of rotator cuff footprint.

Arm Title

Mechanical Debridement

Arm Type

Active Comparator

Arm Description

Standard mechanical debridement of rotator cuff footprint.

Intervention Type

Procedure

Intervention Name(s)

Coblation Debridement (FLOW90)

Intervention Description

bipolar radiofrequency energy

Primary Outcome Measure Information:

Title

Western Ontario Rotator Cuff Score (WORC)

Description

Shoulder based quality of life measurement tool

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Western Ontario Rotator Cuff Score (WORC)

Description

Shoulder based quality of life measurement tool

Time Frame

3 months, 6 months, 12 months

Title

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

Description

Short version of the DASH questionnaire for musculoskeletal disorders of the upper extremity

Time Frame

3 months, 6 months, 12 months, 24 months

Title

Re-tear of rotator cuff

Description

Evaluated via MRI

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ian Lo, MD FRCSC

Phone

403-284-4062

ikylo@ucalgary.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Kristie More, MSc

Phone

403-284-4062

kristie.more@ucalgary.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ian Lo, MD FRSCS

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Access Orthopaedics

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2R2G5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristie More, MSc

Phone

403-284-4062

kristie.more@ucalgary.ca

First Name & Middle Initial & Last Name & Degree

Deanne Meredyk

Phone

403-284-4062

shoulder@ucalgary.ca

12. IPD Sharing Statement

Plan to Share IPD

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Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement

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