Rotator Cuff TearsFLOW90NCT05084781
Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement
A study testing Coblation Debridement (FLOW90) in people with Rotator Cuff Tears, run by University of Calgary at 1 site in Canada.
Trial summary
Randomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Coblation Debridement (FLOW90)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jul 2020to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Access Orthopaedics
Calgary, Alberta, T2R2G5
Kristie More, MSc, 403-284-4062, kristie.more@ucalgary.ca
Deanne Meredyk, 403-284-4062, shoulder@ucalgary.ca
About this study
Official title: Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement: A Prospective Randomized Double Blind Controlled Trial
Randomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair.
Read the 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).
- Conditions
- Rotator Cuff Tears
- Being tested
- Coblation Debridement (FLOW90)
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coblation Debridement (FLOW90)Procedure or surgery
bipolar radiofrequency energy
| Study group | Role | What they receive |
|---|---|---|
| Coblation Debridement | Experimental | FLOW 90 / WEREWOLF debridement of rotator cuff footprint. Receives: Procedure: Coblation Debridement (FLOW90) |
| Mechanical Debridement | Active comparator | Standard mechanical debridement of rotator cuff footprint. Receives: Procedure: Coblation Debridement (FLOW90) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Rotator Cuff Score (WORC)
Shoulder based quality of life measurement tool
Measured: 24 months
Secondary outcomes (3)
Western Ontario Rotator Cuff Score (WORC)
Shoulder based quality of life measurement tool
Measured: 3 months, 6 months, 12 months
Quick Disability of the Arm Shoulder and Hand (QuickDASH) questionnaire
Short version of the DASH questionnaire for musculoskeletal disorders of the upper extremity
Measured: 3 months, 6 months, 12 months, 24 months
Re-tear of rotator cuff
Evaluated via MRI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start8 Jul 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paralle study arms for 1)coblation debridement, 2) mechanical debridement
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Lo, MD FRSCS, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084781
- Sponsor's protocol ID
- REB19-1158
- Acronym
- FLOW90
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement: A Prospective Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT05084781
- Acronym / sponsor ID
- FLOW90 / REB19-1158
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Paralle study arms for 1)coblation debridement, 2) mechanical debridement
| Arm | Type | Receives |
|---|---|---|
| Coblation Debridement | Experimental | Procedure: Coblation Debridement (FLOW90)FLOW 90 / WEREWOLF debridement of rotator cuff footprint. |
| Mechanical Debridement | Active comparator | Procedure: Coblation Debridement (FLOW90)Standard mechanical debridement of rotator cuff footprint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coblation Debridement (FLOW90)bipolar radiofrequency energy | Procedure or surgery | Coblation Debridement, Mechanical Debridement |
Primary outcome
Western Ontario Rotator Cuff Score (WORC)
Time frame: 24 months
Shoulder based quality of life measurement tool
3 secondary outcomes
Western Ontario Rotator Cuff Score (WORC)
Time frame: 3 months, 6 months, 12 months
Quick Disability of the Arm Shoulder and Hand (QuickDASH) questionnaire
Time frame: 3 months, 6 months, 12 months, 24 months
Re-tear of rotator cuff
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Lo, MD FRSCS principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coblation Debridement (FLOW90) in people with Rotator Cuff Tears, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ian Lo, MD FRCSC (403-284-4062, ikylo@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Rotator Cuff Score (WORC) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.