Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
08/H1005/47
Study information
Scientific title
The use of biodegradable fixation system for closed fractures of the ankle
Acronym
Study hypothesis
There is a clinical difference in using biodegradable fixation methods in ankle fractures.
Ethics approval
Received from the Liverpool Adult Local Ethics Committee on the 22nd September 2008 (ref: 08/H1005/47).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/06/2008
Overall trial end date
01/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 - 65 years, either sex
2. Closed ankle fractures
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
146
Participant 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
Recruitment start date
01/06/2008
Recruitment end date
01/06/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wirral University Teaching Hospital NHS Foundation Trust
Wirral
CH49 5PE
United Kingdom
Sponsor information
Organisation
Wirral University Teaching Hospital NHS Foundation Trust (UK)
Sponsor details
Arrowe Park Hospital
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
dr_kenyon@hotmail.com
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Inion Ltd (UK) - providing biodegradable plates on a cost-neutral basis
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
No further funding is required or has been requested.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary