Outcomes in using biodegradable fixation materials for fractures of the ankle
| ISRCTN | ISRCTN67973353 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67973353 |
| Secondary identifying numbers | 08/H1005/47 |
- Submission date
- 13/05/2008
- Registration date
- 05/11/2008
- Last edited
- 30/11/2012
- 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 Michael Hennessy
Scientific
Scientific
Wirral University Teaching Hospital NHS Foundation Trust
Arrowe Park Hospital
Arrowe Park Road
Upton
Wirral
CH49 5PE
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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The use of biodegradable fixation system for closed fractures of the ankle |
| Study objectives | There is a clinical difference in using biodegradable fixation methods in ankle fractures. |
| Ethics approval(s) | Received from the Liverpool Adult Local Ethics Committee on the 22nd September 2008 (ref: 08/H1005/47). |
| Health condition(s) or problem(s) studied | Closed fractures of the ankle |
| Intervention | All patients who meet the inclusion criteria will be identified on admission and given the choice of entering the trial at which point they will sign a consent form. Patients can exit the trial at any point. Two cohorts of patients will exist, those for traditional fixation with a neutralisation plate, screws and medial malleolar screws, and there will also be those who have the biodegradable implants used. Randomisation will be done using block randomisation. Four treatments, two of each kind, will be allocated to the block. All combinations for the order of treatment will be included. Consequently there will be six blocks. A random number generator will then be use to allocated a block of treatment to each sequence of four successive patients. |
| Intervention type | Other |
| Primary outcome measure | 1. The American Orthopaedic Foot and Ankle Society (AOFAS) ankle score 2. Visual Analogue Scale score 3. Olerud and Molander score Patients will be followed up on a routine basis at 3 months and 6 months. |
| Secondary outcome measures | 1. Time of injury to operation 2. Tourniquet time 3. Past medical history 4. Co-morbidities 5. Smoking history 6. Time non-weight bearing post-operation 7. Further surgery 8. Complications Patients will be followed up on a routine basis at 3 months and 6 months. |
| Overall study start date | 01/06/2008 |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 146 |
| Key inclusion criteria | 1. Aged 18 - 65 years, either sex 2. Closed ankle fractures |
| Key exclusion criteria | 1. Children 2. Open wounds 3. Infection 4. Conditions that limit blood supply to the feet 5. Insufficient quality/quantity of bone 6. Poor patient co-operation (alcoholics/intravenous drug users [IVDUs]) 7. Diabetics 8. Patients with peripheral nerve conditions 9. Adult unable to give consent |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 01/06/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Wirral University Teaching Hospital NHS Foundation Trust
Wirral
CH49 5PE
United Kingdom
CH49 5PE
United Kingdom
Sponsor information
Wirral University Teaching Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Arrowe Park Hospital
Arrowe Park Road
Upton
Wirral
CH49 5PE
England
United Kingdom
| dr_kenyon@hotmail.com | |
| Website | http://www.whnt.nhs.uk/ |
"ROR" |
https://ror.org/05cv4zg26 |
Funders
Funder type
Industry
Inion Ltd (UK) - providing biodegradable plates on a cost-neutral basis
No information available
No further funding is required or has been requested.
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 |
