Superior Capsule vs Bridging Study (SCR)

University of Calgary

Status: Completed

Conditions: Rotator Cuff Tears

Treatments: Procedure: Bridging; Procedure: SCR

Study type: Interventional

Funder types: Other

Identifiers

NCT04965103

REB15-1787

Details and patient eligibility

About

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

Full description

RCT n = 50

Groups:

1. bridging
2. SCR

Outcomes:

1. WORC
2. ASES
3. QuickDASH
4. MRI at 12 months post-op

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Bridging

Active Comparator group

Description:

Tendon repair with graft interposition

Treatment:

Procedure: Bridging

SCR

Experimental group

Description:

Superior Capsule reconstruction

Treatment:

Procedure: SCR