Shoulder Arthroplasty Trial
| ISRCTN | ISRCTN18607924 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18607924 |
| Protocol serial number | 11130 |
| Sponsor | University of Warwick (UK) |
| Funder | NIHR Research for Patient Benefit Programme (UK) (ref: PB-PG-0110-21121) |
- Submission date
- 12/12/2012
- Registration date
- 12/12/2012
- Last edited
- 16/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Damian Griffin
Scientific
Scientific
University of Warwick
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
| damian.griffin@warwick.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial of total resurfacing versus hemi resurfacing in the treatment of primary osteoarthritis of the shoulder |
| Study objectives | A randomised controlled trial of total resurfacing versus hemi resurfacing in the treatment of primary osteoarthritis. |
| Ethics approval(s) | First MREC, 30/08/2011, ref: 11/WM/0245 |
| Health condition(s) or problem(s) studied | Musculoskeletal disease |
| Intervention | Hemi Resurfacing Arthroplasty: The humeral head is resurfaced and the glenoid remains intact with no surgical intervention Total Resurfacing Arthroplasty: Total Resurfacing Shoulder Arthroplasty. The glenoid and humeral head is resurfaced. Followed up at 12 months |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Oxford Shoulder Score, measured at baseline, 6 weeks, 3 months, 6 months and 12 months |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Patient has severe osteoarthritis of the shoulder 2. Patient is suitable for a total resurfacing of the shoulder 3. Patient is medically fit for surgery 4. Patients aged 18 years of age or older 5. Male or female participants |
| Key exclusion criteria | 1. Patients unlikely to be able to adhere to trial procedures 2. Patients not able to provide informed consent |
| Date of first enrolment | 31/01/2012 |
| Date of final enrolment | 30/04/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Warwick
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/11/2016: No publications found, verifying study status with principal investigator.
