Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
12/07/2016
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

Ms Bridget Gray

ORCID ID

Contact details

Kadoorie Centre for Critical Care Research
Level 3
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

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 measures

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

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

http://www.oxfordradcliffe.nhs.uk/home.aspx

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/07/2016: No publications found, study status unverified