Contact information
Type
Scientific
Primary contact
Prof Damian Griffin
ORCID ID
Contact details
Warwick Medical School
Clinical Sciences Building
Research Wing
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 (0)2476 968618
damian.griffin@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15964
Study information
Scientific title
Improved functional outcome in heel fracture with surgical treatment versus non-operative care: a randomised controlled trial
Acronym
Study hypothesis
Surgical treatment leads to improved functional outcome compared with non-operative care.
Please note that as of 09/02/2009 the trial start and end dates of this record were updated. The initial dates at the time of registration were:
Initial anticipated start date: 01/01/2006
initial anticipated end date: 30/06/2010
Ethics approval
Oxfordshire REC A, 24/05/2006, ref: 06/Q1604/58
Study design
Observer blind randomised controlled 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
Calcaneal fracture
Intervention
Intervention: open reduction and internal fixation by extensile lateral approach
Control: non-surgical treatment with elevation and ice followed by spintage and early mobilisation
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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)
Secondary outcome measures
Amended as of 09/02/2009:
Point four has been amended as follows:
4. Gait and foot pressure analysis using F-Scan for gait analysis. This is an in shoe pressure system which also enables objective assessment of various parameters of gait.
Initial information at time of registration:
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.
Overall trial start date
01/06/2006
Overall trial end date
30/11/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Closed displaced intra-articular fractures of the calcaneus
2. Aged over 18 years, no upper age limit, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150; 75 in each group
Participant exclusion criteria
Amended as of 09/02/2009:
1. Calcaneal fracture with severe deformity resulting in fibula impingement
2. Previous calcaneal abnormality (infection, tumour or deformity)
3. Other serious injuries to either lower limb that would interfere with rehabilitation of the index calcaneal fracture
4. Peripheral vascular disease (defined as having been investigated or treated for poor lower limb circulation)
5. Other contra-indication to surgery, defined as:
5.1. Severe cardiac impairment, e.g. heart or valve replacement, arrhythmia, previous myocardial infarction
5.2. Severe respiratory impairment, e.g. chronic obstructive pulmonary disease, asthma that has required hospital admission
5.3. Any other systemic medical condition that would produce a specific contraindication to a general anaesthetic
6. Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as dementia or intravenous drug abuse
Initial information at time of registration:
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
Recruitment start date
01/06/2006
Recruitment end date
30/11/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Warwick Medical School
Coventry
CV2 2DX
United Kingdom
Sponsor information
Organisation
University Hospitals Coventry and Warwickshire NHS Trust (UK)
Sponsor details
University Hospital
Walsgrave
Coventry
CV2 2DX
United Kingdom
+44 (0)2476 602020
info@uhcw.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (ARC) (UK) (ref: 15964)
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25059747
Publication citations
-
Results
Griffin D, Parsons N, Shaw E, Kulikov Y, Hutchinson C, Thorogood M, Lamb SE, , Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial., BMJ, 2014, 349, g4483.