Superior Capsule vs Bridging Study

Rotator Cuff Tears Clinical Trial

— SCR  

Official title:

Graft Reconstruction for Irreparable Rotator Cuff Tears: Superior Capsule Reconstruction or Tendon Repair With Graft Interposition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04965103
• Other study ID #: REB15-1787
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized controlled trial examining superior capsule reconstruction versus tendon repair with graft interposition in "irreparable" rotator cuff tears.

Description:

RCT n = 50

Groups:

1. bridging

2. SCR

Outcomes:

1. WORC

2. ASES

3. QuickDASH

4. MRI at 12 months post-op

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: November 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Large to massive rotator cuff tear (with or without subscapularis tear) that may possibly be irreparable without the use of graft materials (confirmed intra-operatively)

2. Either primary tear or re-tear after previous repair

3. Radiographic evidence of Hamada stage 1-3, with or without Samilson & Prieto mild osteoarthritis (<3mm inferior osteophyte)

Exclusion Criteria:

1. Primary glenohumeral osteoarthritis: radiographic evidence of Samilson & Prieto classification moderate or greater

2. Cuff tear arthropathy (CTA): radiographic evidence of Hamada stage 4 or above

3. Inflammatory joint disease of the shoulder (e.g. rheumatoid arthritis)

4. Medical issues precluding surgery

5. Unwilling or unable to complete study outcomes

6. Worker's Compensation Claim or litigation

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• SCR
Superior Capsule reconstruction
• Bridging
Tendon repair with graft interposition

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Arthroscopy Association of North America (funding), Canadian Orthopaedic Foundation (funding), Worker's Compensation Board of Alberta (funding)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Shoulder and Elbow Surgeon Outcome - patient portion	American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)	24 months
Primary	American Shoulder and Elbow Surgeon Outcome - patient portion	American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)	12 months
Primary	American Shoulder and Elbow Surgeon Outcome - patient portion	American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)	6 months
Primary	American Shoulder and Elbow Surgeon Outcome - patient portion	American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)	3 months
Secondary	Western Ontario Rotator Cuff Index	Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)	24 months
Secondary	Western Ontario Rotator Cuff Index	Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)	12 months
Secondary	Western Ontario Rotator Cuff Index	Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)	6 months
Secondary	Western Ontario Rotator Cuff Index	Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)	3 months
Secondary	Disabilities of the Arm, Shoulder and Hand - QuickDASH	Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)	24 months
Secondary	Disabilities of the Arm, Shoulder and Hand - QuickDASH	Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)	12 months
Secondary	Disabilities of the Arm, Shoulder and Hand - QuickDASH	Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)	6 months
Secondary	Disabilities of the Arm, Shoulder and Hand - QuickDASH	Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)	3 months
Secondary	Tendon healing, assessed via MRI	Tendon healing (classifications: intact or retorn)	12 months