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Coblation Debridement for Rotator Cuff Repair (FLOW90 Trial)

N/A
Recruiting
Led By Ian Lo, MD FRSCS
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject is at least eighteen (18) years of age and considered to be skeletally mature
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
Must not have
The subject requires a concomitant labral repair
The subject has undergone previous rotator cuff repair surgery to the affected shoulder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months, 12 months, 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial found that coblation debridement is just as effective as mechanical debridement in rotator cuff repair.

Who is the study for?
This trial is for adults over 18 with a repairable full-thickness rotator cuff tear smaller than 5cm, who have tried other treatments like physical therapy or steroid injections without success. They must be able to get an MRI and commit to follow-up visits. People with partial tears, irreparable tears, high operative risks, severe fatty atrophy of the muscle, or those involved in litigation or compensation cases cannot join.
What is being tested?
The study is testing two methods of preparing the bone before repairing a torn rotator cuff: coblation debridement (using FLOW90) versus mechanical debridement. Participants will be randomly assigned to one of these treatment groups in this controlled trial.
What are the potential side effects?
Potential side effects may include discomfort at the surgery site, swelling, infection risk increase due to surgery, and possible complications related to shoulder movement post-operation. Specific side effects from coblation versus mechanical debridement are not detailed but could vary based on individual healing responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and my bones have stopped growing.
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I have a shoulder injury confirmed by MRI or ultrasound to be less than 5cm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need surgery to fix a tear in the cartilage of my hip.
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I have had surgery to repair the rotator cuff in my shoulder.
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I have a shoulder injury that cannot be fixed with surgery.
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I need surgery to repair a tear in my labrum with stitches.
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I have a serious illness and my doctor thinks I have less than 2 years to live.
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I have a partial tear in my shoulder's rotator cuff.
Select...
I currently have an infection near my surgery area.
Select...
My rotator cuff tear is too large or cannot be fixed during surgery.
Select...
I cannot or do not want to have an MRI scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months, 12 months, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Western Ontario Rotator Cuff Score (WORC)
Secondary study objectives
Quick Disability of the Arm Shoulder and Hand (QuickDASH) questionnaire
Re-tear of rotator cuff

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Coblation DebridementExperimental Treatment1 Intervention
FLOW 90 / WEREWOLF debridement of rotator cuff footprint.
Group II: Mechanical DebridementActive Control1 Intervention
Standard mechanical debridement of rotator cuff footprint.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,720 Total Patients Enrolled
4 Trials studying Rotator Cuff Tears
417 Patients Enrolled for Rotator Cuff Tears
Ian Lo, MD FRSCSPrincipal InvestigatorUniversity of Calgary

Media Library

Coblation Debridement (FLOW90) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05084781 — N/A
Rotator Cuff Tears Research Study Groups: Coblation Debridement, Mechanical Debridement
Rotator Cuff Tears Clinical Trial 2023: Coblation Debridement (FLOW90) Highlights & Side Effects. Trial Name: NCT05084781 — N/A
Coblation Debridement (FLOW90) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05084781 — N/A
~2 spots leftby Dec 2024
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