A combined randomised and observational study of surgical repair of rotator cuff tears in adults

Not Applicable

Recruiting

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

• Registration Number: ACTRN12620000789965
• Lead Sponsor: The University of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-05
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

•Age 45 – 75 years inclusive
•Complete tear of supraspinatus tendon on Magnetic Resonance Imaging (MRI), confirmed at diagnostic arthroscopy as being:
oComplete
owith or without extension into infraspinatus or superior 1/3 of subscapularis tendons
o1 to 4cm tear in anteroposterior length
•At least 6 months duration of shoulder symptoms (regardless of non-operative treatment)
•English speaking
•Available for post-operative rehabilitation and for follow up for at least 6 months

Exclusion Criteria

•Pregnancy
•Tear extending beyond superior 1/3 of subscapularis tendon
• Prior surgery to affected shoulder
• Stage 3 or higher fatty atrophy of infraspinatus and positive Tangent sign according to standardised MRI protocol
• Glenohumeral osteoarthritis (Outerbridge Grade III or higher measured during arthroscopy) or loss of joint space or osteophyte on pre-operative imaging
•Frozen shoulder (>50% loss global passive range) and/or capsular release
• Significant acromio-clavicular (AC) joint symptoms (defined as AC joint tenderness)
•A traumatic tear (more than a fall from standing height) that has occurred within the last six months
• Current use of oral glucocorticoids, immunosuppressants
• Rheumatoid arthritis or other autoimmune inflammatory arthropathy
• Shoulder instability
• Osteonecrosis of the humeral head
• Resident of a residential aged care facility
• Shoulder condition covered by workers’ compensation insurance
• Limited English proficiency or cognitive impairment precluding fully informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Western Ontario Rotator Cuff (WORC) index score. The WORC is a quality of life questionnaire specific to rotator cuff tendinopathy. Superiority of rotator cuff repair will require a minimum clinically important difference (MCID) of 0.5SD in the WORC Index, based on a distribution method of determining the MCID.[6 months post surgery.]