Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement

Rotator Cuff Tears Clinical Trial

— FLOW90  

Official title:

Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement: A Prospective Randomized Double Blind Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084781
• Other study ID #: REB19-1158
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2021
• Source: University of Calgary
• Contact: Ian Lo, MD FRCSC
• Phone: 403-284-4062
• Email: ikylo[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• Coblation Debridement (FLOW90)
bipolar radiofrequency energy

Locations

Country	Name	City	State
Canada	Access Orthopaedics	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario Rotator Cuff Score (WORC)	Shoulder based quality of life measurement tool	24 months
Secondary	Western Ontario Rotator Cuff Score (WORC)	Shoulder based quality of life measurement tool	3 months, 6 months, 12 months
Secondary	Quick Disability of the Arm Shoulder and Hand (QuickDASH) questionnaire	Short version of the DASH questionnaire for musculoskeletal disorders of the upper extremity	3 months, 6 months, 12 months, 24 months
Secondary	Re-tear of rotator cuff	Evaluated via MRI	12 months