Analysing genes, blood, urine and clinical outcomes in people with frozen shoulder, rotator cuff tears and osteoarthritis

Not Applicable

Recruiting

• Conditions: Adhesive capsulitis; shoulder instability; shoulder osteoarthritis; rotator cuff tear; Musculoskeletal - Other muscular and skeletal disorders; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12618000431224
• Lead Sponsor: Barwon Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-26
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria (AC and control):
•Adults 18 – 70 yrs
•Symptoms > 3mths
•Imaging
oMRI – exclusion of degenerative or inflammatory arthropathy, as well as stage full thickness rotator cuff tears
•Instability > 1 episode for controls, pain only a minor feature
•AC – Global loss of motion > 30%
Inclusion criteria (rotator cuff tear)
•18 to 70 years of age
•Symptoms > 6 months (chronic tear)
•Full thickness rotator cuff tear on MRI
Inclusion criteria (shoulder arthritis)
•18 to 85 years of age
•Primary OA
•Symptoms > 6 months
•Xray changes consistent with OA
oOA only group: without full thickness rotator cuff tear on US or MRI
oRotator cuff arthropathy group: x-ray indicating high humeral head

Exclusion Criteria

Exclusion Criteria (AC and control):
•Post surgical restricted motion
•Instability episode < 8wks prior – for control group
•Imaging – MRI features – not fulfilling criteria
Exclusion criteria (rotator cuff tear)
•Isolated subscapularis tears
•Reduced motion (<50% range) affecting daily living with clinical features of adhesive
•Massive tears (> 2 tendons)
•Prior shoulder surgery in the affected shoulder
•Intra-articular or intra-bursal corticosteroid injection within the preceding three months.
Exclusion criteria (shoulder arthritis)
•Rheumatoid arthritis or seronegative arthropathies
•Type C glenoid
•Prior shoulder surgery or significant trauma/fracture
•Intra-articular or intra-bursal corticosteroid injection within the preceding three months.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exploratory study of gene expression using RNA-seq on tissue samples collected from the anterior glenohumeral joint capsule[Intra-operative tissue sample];Exploratory biomarker gene analysis using plasma and urine samples.[Shortly before surgery]

Secondary Outcome Measures

Name	Time	Method
Shoulder pain and function assessed by the Oxford Shoulder Score[Preoperatively and 12-months postoperatively.]; Active range of shoulder movement visually estimated by orthopaedic surgeon[Preoperatively and 12-months post-operatively]; Oxford Shoulder Instability Score[Preoperatively and 12-months postoperatively];Upper limb symptoms and function assessed by the Quick DASH[Preoperatively and 12-months postoperatively];Shoulder pain, function and instability assessed by the American Shoulder and Elbow Society Score[Preoperatively and 12-months postoperatively];Quality of life assessed by the EQ-5D-5L[Preoperatively and 12-months postoperatively]