Is a neutralisation plate always necessary in the treatment of unstable ankle fractures?
| ISRCTN | ISRCTN87522845 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87522845 |
| Secondary identifying numbers | N0034136470 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 16/12/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Mr Jonathan McGregor-Riley
Scientific
Scientific
Barnsley Hospital
Barnsley
S75 2EP
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Is a neutralisation plate always necessary in the treatment of unstable ankle fractures? |
| Study objectives | To ascertain whether the avoidance of a plate will minimise soft tissue problems and lateral hardware associated pain and hence reduce the need for the removal of metalwork whilst maintaining adequate fracture fixation |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Injury, Occupational Diseases, Poisoning: Ankle fractures |
| Intervention | Neutralisation plate vs standard practice |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Efficacy of treatment |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2002 |
| Completion date | 01/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | All adults over 18 years of age admitted to this Trust will be randomised. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 01/04/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Barnsley Hospital
Barnsley
S75 2EP
United Kingdom
S75 2EP
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Barnsley District General Hospital NHS Trust (UK)
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 |
