Painful osteoarthritis of the shoulder joint Musculoskeletal Diseases
Conditions
Interventions
Eligible and consenting patients will be randomly allocated to either anatomical total shoulder replacement (aTSR) or reverse total shoulder replacement (rTSR). Only non-augmented replacements will be
70+) as a surrogate of deteriorating shoulder rotator cuff function. The allocation schedule will be generated by a trial statistician, otherwise not involved in the recruitment or randomisation of pa
Sponsors
Wrightington, Wigan and Leigh NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
60 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged =60 years 2. Diagnosis of painful osteoarthritis of the glenohumeral joint using routine radiographs not controlled by previous interventions 3. An intact rotator cuff determined by pre-operative advanced imaging (Ultrasound, MRI, or CT) 4. Minimal glenoid erosion determined by pre-operative CT or other imaging in whom a non-augmented replacement is appropriate 5. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Shoulder replacement surgery contra-indicated 2. A diagnosis of inflammatory arthritis, acute trauma or trauma sequelae 3. Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires 4. Trial participant for TSR for opposite shoulder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported shoulder pain and function measured using combined Shoulder Pain and Disability Index (SPADI) score at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/09/2025: 1. Pain and function measured using total SPADI score at 3, 6, 12, 18, and 24 months 2. Quality of life measured using individual subscales of pain and disability from SPADI, Oxford Shoulder Score (OSS), and EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaires at 3, 6, 12, 18 (SPADI only) and 24 months 3. Global perceived effect is measured by asking the patient at 24 months for their opinion about the change in their shoulder since the start of the trial using a 5-point Likert scale 4. Resource use measured using a patient-reported questionnaire at 3, 6, 12, and 24 months 5. Re-operations and complications measured from medical records at 3, 6, 12, and 24 months, also complications specific to the arthroplasty implant (e.g. glenoid loosening) will be reviewed by the local surgeon using post-operative and 24-month radiographs 6. Objective assessments using shoulder range of movement and strength and global shoulder score at 24 months 7. Revisions and mortality measured from medical records at 24 months Previous secondary outcome measures: 1. Pain and function measured using total SPADI score at 3, 6, 12, 18, and 24 months 2. Quality of life measured using individual subscales of pain and disability from SPADI, Oxford Shoulder Score (OSS), and EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaires at 3, 6, 12, 18 (SPADI only) and 24 months 3. Resource use measured using a patient-reported questionnaire at 3, 6, 12, and 24 months 4. Re-operations and complications measured from medical records at 3, 6, 12, and 24 months 5. Objective assessments using shoulder range of movement and strength and global shoulder score at 24 months 6. Revisions and mortality measured from medical records at 24 months. | — |
Countries
England, Northern Ireland, United Kingdom, Wales
Contacts
Public ContactStephen Brealey
Outcome results
None listed