Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis (in adults 60 years and over): Differences between Interventions (RAPSODI-AUS)
- Conditions
- Painful Shoulder OsteoarthritisMusculoskeletal - OsteoarthritisSurgery - Surgical techniques
- Registration Number
- ACTRN12622001364763
- Lead Sponsor
- Deakin University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 430
Inclusion criteria
•Aged 60 years and over.
•Diagnosis of painful osteoarthritis of the glenohumeral joint using routine radiographs not controlled by previous interventions.
•An intact rotator cuff determined by pre-operative advanced imaging (Ultrasound, MRI, or CT).
•Minimal glenoid erosion determined by pre-operative CT or other imaging in whom a non-augmented replacement is appropriate.
•Able to give informed consent.
Exclusion Criteria
•Shoulder replacement surgery contra-indicated.
•A diagnosis of inflammatory arthritis, acute trauma or trauma sequelae.
•Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires.
•Trial participant for TSR for opposite shoulder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient-reported shoulder pain and function as assessed by the combined Shoulder Pain and Disability Index (SPADI) score. <br>The 13-item SPADI is a validated and sensitive instrument for use in shoulder arthroplasty that assesses two domains; pain (5 items) and functional activities (8 items) on numerical rating scales, to provide a combined score.[ 24 months post-procedure];Combined pain and disability score: measured via the combined SPADI score at preoperative/baseline and at 3, 6, 12, 18 months and over 24 months post-procedure. This will be assessed as a composite outcome.[ 24 months post-procedure]
- Secondary Outcome Measures
Name Time Method