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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months, 12 months, 24 months
Awards & highlights
FLOW90 Trial 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.Check my eligibility
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.See study design
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.
FLOW90 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and my bones have stopped growing.
Select...
I have a shoulder injury confirmed by MRI or ultrasound to be less than 5cm.
FLOW90 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months, 6 months, 12 months, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months, 12 months, 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Quick Disability of the Arm Shoulder and Hand (QuickDASH) questionnaire
Re-tear of rotator cuff
Western Ontario Rotator Cuff Score (WORC)
FLOW90 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
792 Previous Clinical Trials
869,060 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery to fix a tear in the cartilage of my hip.I have had surgery to repair the rotator cuff in my shoulder.I have had pain and disability for over 3 months despite trying treatments like physical therapy.I have a shoulder injury that cannot be fixed with surgery.I need surgery to repair a tear in my labrum with stitches.I have a serious illness and my doctor thinks I have less than 2 years to live.I have a partial tear in my shoulder's rotator cuff.I have not taken any experimental drugs or used approved drugs for experimental purposes in the last 30 days.I can move on my own and can attend all required follow-up visits.I currently have an infection near my surgery area.My rotator cuff tear is too large or cannot be fixed during surgery.I am 18 or older and my bones have stopped growing.I cannot or do not want to have an MRI scan.I have a shoulder injury confirmed by MRI or ultrasound to be less than 5cm.
Research Study Groups:
This trial has the following groups:- Group 1: Coblation Debridement
- Group 2: Mechanical Debridement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scale of patient participation in this clinical investigation?
"Affirmative. Evidently, clinicaltrials.gov documents that this medical experiment began on 8th July 2020 and has been refreshed as of 6th October 2021; 94 individuals are sought from a single location to participate in the trial."
Answered by AI
Are there any spots available to join this clinical experiment?
"According to the information presently available on clinicaltrials.gov, this clinical trial is actively recruiting individuals for participation. The initial post was published on July 8th 2020 and it has been recently updated as of October 6th 2021."
Answered by AI
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