Condition category
Injury, Occupational Diseases, Poisoning
Date applied
13/05/2008
Date assigned
05/11/2008
Last edited
30/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Michael Hennessy

ORCID ID

Contact details

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

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

http://www.whnt.nhs.uk/

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

Publication citations

Additional files

Editorial Notes