None listed
Conditions
Brief summary
Adhesive capsulitis (AC), rotator cuff tears (RCT) and osteoarthritis (OA) is a disabling and poorly understood pathological conditions of the shoulder joint. The current study aims to increase our understanding of the pathogenesis, diagnosis and clinical outcomes of people with AC, RCT and OA by investigating: 1) transcriptome-wide alterations in gene expression of the glenohumeral joint capsule compared to people with non-inflammatory shoulder instability (controls); 2) serum and urine biomarkers to better understand diagnosis and staging of AC, RCT and OA; and 3) clinical outcomes in people with AC, RCT and OA compared to controls 12-months following arthroscopic capsular release or labral repair respectively. The study is a multi-centre, non-randomised study investigating people undergoing surgery for AC, RCT and OA compared to people undergoing arthroscopic stabilization for shoulder instability. Tissue samples collected from the anterior glenohumeral joint capsule during surgery will undergo RNA-seq to determine differences in gene expression between the study groups. Gene Set Enrichment Analysis will be used to further understand the pathogenesis of AC as well as guide serum and urine biomarker analysis. Clinical outcomes regarding pain, function and quality of life will be assessed using the Oxford Shoulder Score, Oxford Shoulder Instability Score, Quick DASH, American Shoulder and Elbow Society Score, EQ-5D-5L and active shoulder range of movement. Clinical outcomes will be collected pre-operatively and 12-months post-operatively and study groups will be compared for statistically significant differences (p<0.05).
Interventions
All participants receive general anaesthetic and interscalene block, and will be placed in the beach chair or lateral position consistent with published guidelines. During the arthroscopy by an orthopaedic surgeon, two punch biopsies the size of rice grain will be collected under direct arthroscopic vision from the anterior capsule and rotator interval of the glenohumeral joint. Tissue samples are immediately placed in a vial containing RNAlaterTM stabilization solution (ThermoFisher).
Particip
All participants receive general anaesthetic and interscalene block, and will be placed in the beach chair or lateral position consistent with published guidelines. During the arthroscopy by an orthopaedic surgeon, two punch biopsies the size of rice grain will be collected under direct arthroscopic vision from the anterior capsule and rotator interval of the glenohumeral joint. Tissue samples are immediately placed in a vial containing RNAlaterTM stabilization solution (ThermoFisher). Participants' shoulders from the AC group will be accessed with three arthroscopic portals and saline arthroscopic fluid at room temperature inserted into the joint space. Biopsies will be taken by the surgeon and rotator interval release conducted via an incision of the anterior capsule with the radiofrequency probe in the 1.00 to 5.30 position. Range of motion will be compared to the unaffected shoulder and a limited posterior capsule release performed by reversing the arthroscopic view if ranges are not equal. The operation time is approximately 60 minutes.
Sponsors
Barwon Health
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria (AC and control): • Adults 18 – 70 yrs • Symptoms > 3mths • Imaging o MRI – 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 o OA only group: without full thickness rotator cuff tear on US or MRI o Rotator 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.
Outcome results
None listed