AS04 Ankle study of fracture treatment in the older patient
| ISRCTN | ISRCTN81174170 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81174170 |
| Secondary identifying numbers | 7109 |
- Submission date
- 23/04/2010
- Registration date
- 23/04/2010
- Last edited
- 12/07/2016
- 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
Ms Bridget Gray
Scientific
Scientific
Kadoorie Centre for Critical Care Research
Level 3, Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Study information
| Study design | Randomised interventional 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 | 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 |
| Study acronym | AS04 Ankle study |
| Study objectives | 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(s) | Oxfordshire Research Ethics Committee approved on the 1st August 2003 (ref: C03 071) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2004 |
| Completion date | 31/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 120; UK Sample Size: 120 |
| Key inclusion criteria | 1. Unstable ankle fracture 2. Aged over 60 years, either sex |
| Key exclusion criteria | 1. Open fractures 2. Multiple injuries 3. Type 1 diabetes 4. Active leg ulceration 5. Critical leg ischaemia 6. Unfit for anaesthesia |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 31/07/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Kadoorie Centre for Critical Care Research
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
England
United Kingdom
| Website | http://www.oxfordradcliffe.nhs.uk/home.aspx |
|---|---|
"ROR" |
https://ror.org/03h2bh287 |
Funders
Funder type
Research organisation
AO Research Foundation (Switzerland)
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 |
Editorial Notes
12/07/2016: No publications found, study status unverified
