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ISRCTN
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ISRCTN37188541
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ClinicalTrials.gov identifier
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Public title
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UK heel fracture trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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15964
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Study hypothesis
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Surgical treatment leads to improved functional outcome compared with non-operative care
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Ethics approval
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Ethical approval not yet received
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Study design
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Observer blind, randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Calcaneal fracture
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Participants - inclusion criteria
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Closed displaced intra-articular fractures of the calcaneus
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Participants - exclusion criteria
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1. Diabetes
2. Peripheral vascular disease, or other local or systemic contra-indication to surgery
3. Injury to the ipsilateral leg
4. Very severe deformity with the lateral wall of the calcaneus impinging upon the fibula
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Anticipated start date
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01/01/2006
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Anticipated end date
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30/06/2010
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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150; 75 in each group
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Interventions
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Open reduction and internal fixation by extensile lateral approach.
Control: non-surgical treatment with elevation and ice followed by spintage and early mobilisation.
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Primary outcome measure(s)
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The Kerr Calcaneal Fracture Score. (A validated, reliable, patient-derived outcome instrument for pain and function following calcaneal fracture, accepted by surgeons working in the area).
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Secondary outcome measure(s)
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1. Complications, including wound dehiscence, infection, mal-union, non-union and radiographic arthritis
2. General health using the SF-36 questionnaire
3. American Orthopaedic Foot and Ankle Society Hind Foot Score
4. Gait and foot pressure analysis using GAITRite. (A simple portable pressure sensitive mat connected to a laptop computer that enables objective assessment of various parameters of gait including walking speed, step length, and dynamic contact pressures)
5. Health status using EQ-5D
6. Resource use will be monitored for the economic analysis. National Health Service (NHS) costs will be collated for each trial arm. Cost-consequences will be monitored via short questionnaires. In addition, average time off work or reduced working hours attributed to the condition in both groups will be recorded.
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Sources of funding
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Arthritis Research Campaign 15964
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Trial website
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Publications
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Contact name
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Prof
Damian
Griffin
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Address
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Warwick Medical School
Clinical Sciences Building
Research Wing
Clifford Bridge road
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City/town
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Coventry
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Zip/Postcode
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CV2 2DX
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Country
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United Kingdom
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Tel
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+44 (0)2476 968618
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Fax
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+44 (0)2476 968617
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Email
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damian.griffin@warwick.ac.uk
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Sponsor
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University Hospitals Coventry and Warwickshire NHS Trust (UK)
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Address
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University Hospital
Walsgrave
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City/town
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Coventry
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Zip/Postcode
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CV2 2DX
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Country
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United Kingdom
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Tel
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+44 (0)2476 602020
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Email
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info@uhcw.nhs.uk
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Date applied
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07/02/2006
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Last edited
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22/02/2006
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Date ISRCTN assigned
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22/02/2006
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