Recruiting

Mechanical Bone Debridement vs. Coblation Debridement

Sponsor:

University of Calgary

Code:

NCT05084781

Conditions

Rotator Cuff Tears

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coblation Debridement (FLOW90)

Study Details

Brief summary:

Randomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair.

Conditions

Rotator Cuff Tears

Study ID

NCT05084781

Start date

Jul 8, 2020

Status verified date

Oct, 2021

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. The subject has signed the REB approved informed consent form (ICF) specific to this study prior to enrollment
2. 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
3. The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits
4. The subject has persistent pain and functional disability and has failed conservative treatment (e.g. PT, steroid injection, anti-inflammatory) for > 3 months
5. The subject is at least eighteen (18) years of age and considered to be skeletally mature

Exclusion Criteria:

1. The subject has undergone previous rotator cuff repair surgery to the affected shoulder
2. The subject has a partial thickness rotator cuff tear
3. The subject requires a concomitant labral repair
4. The subject has an irreparable rotator cuff tear
5. The subject is unable or unwilling to undergo MRI scan.
6. The investigator judges the subject unlikely to remain compliant to follow-up.
7. The subject has received an investigational therapy or approved therapy for investigational use within 30 days prior to the surgery
8. The subject is a prisoner, or is known or suspected to be transient
9. The subject's condition represents a worker's compensation case
10. The subject is currently involved in a health-related litigation procedure
11. The subject currently has an acute infection in the area surrounding the surgical site
12. The subject has a major medical illness (life expectancy less than 2 years or unacceptably high operative risk
13. Fatty atrophy >50% (Goutallier grade 4-5)

INTRA-OPERATIVE EXCLUSIONS:

1. Massive or irreparable rotator cuff tear which cannot be mobilized to the midpoint of the footprint of the rotator cuff on the greater tuberosity
2. Co-existing labral pathology requiring repair with sutures

Study Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Coblation Debridement

FLOW 90 / WEREWOLF debridement of rotator cuff footprint.

active comparator: Mechanical Debridement

Standard mechanical debridement of rotator cuff footprint.

Interventions

Coblation Debridement (FLOW90)

bipolar radiofrequency energy

Primary outcome measure

  • Western Ontario Rotator Cuff Score (WORC) [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Locations

Access Orthopaedics

Recruiting

Calgary, Alberta, Canada, T2R2G5

Contacts

More Information

Sponsor

University of Calgary

Last update posted

Oct 20, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2021-10-20.