Coblation Debridement for Rotator Cuff Repair
(FLOW90 Trial)
Trial Summary
What is the purpose of this trial?
Randomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should have failed conservative treatments like physical therapy, steroid injections, or anti-inflammatory medications for more than 3 months, which suggests you may continue these treatments.
What data supports the effectiveness of the treatment Coblation Debridement (FLOW90) for rotator cuff repair?
Research shows that Coblation, a method using plasma energy, effectively reduces bacteria in wounds without spreading them, which suggests it could be beneficial in surgical settings like rotator cuff repair. Additionally, Coblation has been effective in treating other conditions, such as spinal disc issues, indicating its potential versatility and effectiveness in different medical procedures.12345
What makes Coblation Debridement (FLOW90) unique for rotator cuff repair?
Research Team
Ian Lo, MD FRSCS
Principal Investigator
University of Calgary
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgical repair of the rotator cuff with either coblation or mechanical debridement
Post-operative Rehabilitation
Standard post-operative rehab program for all patients
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 3, 6, 12, and 24 months post-operatively
Treatment Details
Interventions
- Coblation Debridement (FLOW90)
Coblation Debridement (FLOW90) is already approved in United States for the following indications:
- Ablation/Debridement of soft tissues and hemostasis of blood vessels in arthroscopic and orthopedic procedures
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor