Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7109
Study information
Scientific title
Influence of ankle skin perfusion on fracture treatment outcomes in the elderly: a randomised controlled trial comparing total contact cast with open reduction and internal fixation, the effect on cutaneous blood supply and relationship to skin complications
Acronym
AS04 Ankle study
Study hypothesis
Current proven treatment methods for ankle fracture in the older patient can be associated with complications due to poor skin, bone or healing. A casting technique, proven successful in treating critical skin breakdown in diabetic patients, has in a local audit shown potential as an alternative treatment in the elderly ankle fracture patient. This study will address the questions:
1. What contribution does the adequacy of the skin blood supply make to healing
2. How does a new cast treatment compare with the 'traditional' open surgical approach with regard to healing and function
Ethics approval
Oxfordshire Research Ethics Committee approved on the 1st August 2003 (ref: C03 071)
Study design
Randomised interventional 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
Topic: Injuries and Accidents; Subtopic: Injuries and Accidents (all Subtopics); Disease: Injuries & Accidents
Intervention
Group A (comparator): ORIF -
Patients will be anaesthetised and have a surgical open reduction and internal fixation by a contemporary method using metal plates and screws.
Group B (intervention): Close Contact Cast -
Patients will be anaesthetised and undergo closed manipulation of the fracture, and then application of a close contact cast.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Functional outcome at 6 months - using the Olerud and Molander Ankle Score - a self reported score
Secondary outcome measures
Skin complications, radiological assessment, quality of life at 6 weeks and 6 months.
Overall trial start date
01/05/2004
Overall trial end date
31/07/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Unstable ankle fracture
2. Aged over 60 years, either sex
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120
Participant exclusion criteria
1. Open fractures
2. Multiple injuries
3. Type 1 diabetes
4. Active leg ulceration
5. Critical leg ischaemia
6. Unfit for anaesthesia
Recruitment start date
01/05/2004
Recruitment end date
31/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Kadoorie Centre for Critical Care Research
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Oxford Radcliffe Hospitals NHS Trust (UK)
Sponsor details
Research and Development Department
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
AO Research Foundation (Switzerland)
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
Basic results (scientific)
Publication list