Superior Capsule vs Bridging Study

Not Applicable

Completed

• Conditions: Rotator Cuff Tears
• Interventions: Procedure: SCR; Procedure: Bridging

• Registration Number: NCT04965103
• Lead Sponsor: University of Calgary

Brief Summary

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

Detailed Description

RCT n = 50

Groups:

1. bridging

2. SCR

Outcomes:

1. WORC

2. ASES

3. QuickDASH

4. MRI at 12 months post-op

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2020-11-07
• Study Completion: 2020-12-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-07-06
• Last Update Submitted: 2021-07-06
• Study First Posted: 2021-07-16
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCR	SCR	Superior Capsule reconstruction
Bridging	Bridging	Tendon repair with graft interposition

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeon Outcome - patient portion	3 months	American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)

Secondary Outcome Measures

Name	Time	Method
Tendon healing, assessed via MRI	12 months	Tendon healing (classifications: intact or retorn)
Western Ontario Rotator Cuff Index	3 months	Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
Disabilities of the Arm, Shoulder and Hand - QuickDASH	3 months	Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)