Shoulder Arthroplasty Trial
| ISRCTN | ISRCTN18607924 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18607924 |
| Secondary identifying numbers | 11130 |
- 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
| Study design | Non-randomised interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | Oxford Shoulder Score, measured at baseline, 6 weeks, 3 months, 6 months and 12 months |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 31/01/2012 |
| Completion date | 30/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 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
- England
- United Kingdom
Study participating centre
University of Warwick
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Sponsor information
University of Warwick (UK)
University/education
University/education
Gibbet Hill Road
Coventry
CV4 7AL
England
United Kingdom
| Website | http://www2.warwick.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
NIHR Research for Patient Benefit Programme (UK) (ref: PB-PG-0110-21121)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
16/11/2016: No publications found, verifying study status with principal investigator.
