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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 4 September 2017
Main ID:  ISRCTN15537280
Date of registration: 24/07/2017
Prospective Registration: Yes
Primary sponsor: University of Warwick
Public title: A clinical trial comparing the effectiveness of a plaster cast to a functional brace in the treatment of adults with ankle fractures
Scientific title: Ankle Injury Rehabilitation - A multi-centre randomised controlled trial to assess the difference between plaster cast and functional bracing in the management of ankle fractures
Date of first enrolment: 01/10/2017
Target sample size: 478
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN15537280
Study type:  Interventional
Study design:  Randomised; Interventional; Design type: Treatment, Complex Intervention, Physical, Rehabilitation (Treatment)  
Phase:  Phase III
Countries of recruitment
United Kingdom
Contacts
Name: Rebecca    Kearney
Address:  Clinical Trials Unit Gibbett Hill Road CV7 4AL Coventry United Kingdom
Telephone: +44 2476 573156
Email: r.s.kearney@warwick.ac.uk
Affiliation: 
Name: Rebecca    McKeown
Address:  Warwick Clinical Trials Unit Warwick Medical School Gibbett Hill Road CV4 7AL Coventry United Kingdom
Telephone: +44 2476 575848
Email: air@warwick.ac.uk
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Provision of written informed consent
2. Aged 18 years or over
3. A closed ankle fracture for which the treating clinician would consider plaster cast a reasonable management option
4. Within 3 weeks of operative treatment or injury if non-operatively managed

Exclusion criteria: 1. Ankle fracture secondary to known metastatic disease
2. Complex intra-articular fracture (e.g. Pilon fracture)
3. In the opinion of the surgeon the patient would require manipulation and close contact casting
4. In the opinion of the surgeon the patient would require manipulation and moulded cast
5. Wound complications following surgical management contraindicating Functional brace intervention
6. Previous ankle fracture randomised in the present trial
7. Evidence that the patient would be unable to adhere to trial procedures or complete postal questionnaires
8. Known pre-existing neuropathic joint disease contraindicating functional brace intervention


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Specialty: Injuries and emergencies, Primary sub-specialty: Musculoskeletal Trauma; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the ankle and foot
Injury, Occupational Diseases, Poisoning
Injuries and Accidents/ Injuries to the ankle and foot
Intervention(s)
All adults with a fractured ankle under the care of a clinician at any of the named recruiting sites are potentially eligible. New patients with an ankle fracture are reviewed each day by the trauma team. Participants are randomised to either receiving either the functional brace or the plaster cast. This process of randomisation is done via a computer generated sequence to determine the treatment to be given.

The plaster cast or functional brace is usually worn from three to eight weeks, which is decided by the treating clinician. The clinician also decides how much weight can be put on the healing ankle.

Participants who receive the functional brace are also be given an exercise sheet, outlining two very simple exercises to maintain and improve the movement in the ankle joint. It is recommended these are completed little and often, as pain allows.

Participants are followed up in this study for a duration of two years and all trial follow up is completed by post. Participants will receive routine follow up by their treating clinician.
Primary Outcome(s)
Symptom evaluation is measured using Olerud Molander Ankle Score questionnaire (this will be collected using patient questionnaires sent via post) at 4 months
Secondary Outcome(s)
1. Symptom evaluation is measured using Olerud Molander Ankle Score questionnaire at six weeks, 10 weeks, six months and 24 months
2. Surgical outcomes are measured using the Manchester-Oxford Foot and Ankle Questionnaire at four months
3. Health status is measured using EuroQol five dimensions questionnaire (EQ-5D) at “6 weeks, 10 weeks, 16 weeks, 24 weeks, 12 months, 18 months and 24 months.
4. Disability is measured using the disability rating index at “6 weeks, 10 weeks, 16 weeks, 24 weeks, 12 months, 18 months and 24 months
5. Cost is measured using a patient reported questionnaire at “6 weeks, 10 weeks, 16 weeks, 24 weeks, 12 months, 18 months and 24 months
6. Complication rate is measured using a patient reported questionnaire at “6 weeks, 10 weeks, 16 weeks, 24 weeks, 12 months, 18 months and 24 months
Secondary ID(s)
35014
Source(s) of Monetary Support
National Institute for Health Research
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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