Comparing the post-operative clinical and radiological outcome between surgical rotator cuff repair and scaffold augmentation for symptomatic rotator cuff tears in the shoulder

Not Applicable

Recruiting

• Conditions: Shoulder Rotator Cuff Tears; Musculoskeletal - Other muscular and skeletal disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12620000926932
• Lead Sponsor: Smith and Nephew

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-17
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Inclusion Criteria
• Age 35-75 years,
• Duration of symptoms (DOS) >3 months,
• Unsuccessful conservative treatment comprising physiotherapy and/or a corticosteroid injection,
• A high grade (50% or more) partial thickness rotator cuff tear as noted on a 3-Tesla MRI scan.

Exclusion Criteria

Exclusion Criteria
• Revision surgery or multi-tendon tears/pathology,
• Cervical pathology and/or concomitant upper limb pathology (e.g. arthritis, nerve compression),
• Adhesive capsulitis, clinical shoulder instability or previous fracture,
• Infection,
• Pregnancy and lactation,
• Professional athlete,
• Worker’s compensation or compensable claim,
• Substance abuse or current mental illness,
• Smoker,
• Known adverse reaction to bovine derived products.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Western Ontario Rotator Cuff Index (WORC) - the WORC produces an overall composite score derived from five specific health/function domains, including physical symptoms, sport and recreation capacity, work ability, lifestyle concerns and emotional concerns, specifically due to the shoulder condition/state.[ 3 months post-surgery]