A randomised trial of ankle joint replacements
| ISRCTN | ISRCTN66721986 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66721986 |
| Protocol serial number | N0284126103 |
| Sponsor | Department of Health |
| Funder | Wrightington, Wigan and Leigh NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Peter Wood
Scientific
Scientific
Wrightington, Wigan & Leigh NHS Trust, Wright
Wrightington Hospital
Hall Lane
Appley Bridge
Wigan
WN6 9EP
United Kingdom
| peter.wood@wiganlhs-tr.nwest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare the long term performance of ankle joint replacements - STAR and BP. Current literature states that there is no long term difference between the two prosthesis |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Ankle replacement |
| Intervention | Long term follow up, in terms of range of motion, x-ray assessment and gait analysis on selected patients. Recruit over two years and follow up for 10 years |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
A long term clinical comparison of two ankle replacements |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 03/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients with Scandinavian Total Ankle Replacement (STAR) and Buechel-Pappas (BP) total ankle replacements |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 03/01/2000 |
| Date of final enrolment | 03/01/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Wrightington, Wigan & Leigh NHS Trust, Wright
Wigan
WN6 9EP
United Kingdom
WN6 9EP
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? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2009 | Yes | No |
