Superior Capsule vs Bridging Study

University of Calgary50 enrolled

Overview

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

RCT n = 50 Groups: 1. bridging 2. SCR Outcomes: 1. WORC 2. ASES 3. QuickDASH 4. MRI at 12 months post-op

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rotator Cuff Tears

Interventions

SCRPROCEDURE

Superior Capsule reconstruction

BridgingPROCEDURE

Tendon repair with graft interposition

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 24 months

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)

Time frame: 12 months

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)

Time frame: 6 months

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)

Time frame: 3 months

Secondary Outcomes

Western Ontario Rotator Cuff Index

Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)

Time frame: 24 months

Western Ontario Rotator Cuff Index

Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)

Time frame: 12 months

Western Ontario Rotator Cuff Index

Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)

Time frame: 6 months

Data from ClinicalTrials.gov

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