Outcomes in using biodegradable fixation materials for fractures of the ankle

ISRCTN	ISRCTN67973353
DOI	https://doi.org/10.1186/ISRCTN67973353
Protocol serial number	08/H1005/47
Sponsor	Wirral University Teaching Hospital NHS Foundation Trust (UK)
Funders	Inion Ltd (UK) - providing biodegradable plates on a cost-neutral basis, No further funding is required or has been requested.

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

Wirral University Teaching Hospital NHS Foundation Trust
Arrowe Park Hospital
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Wirral University Teaching Hospital NHS Foundation Trust

Wirral
CH49 5PE
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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes