UK heel fracture trial: surgical treatment versus non-operative care

ISRCTN	ISRCTN37188541
DOI	https://doi.org/10.1186/ISRCTN37188541
Secondary identifying numbers	15964

Submission date: 07/02/2006
Registration date: 22/02/2006
Last edited: 28/07/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Damian Griffin
Scientific

Warwick Medical School
Clinical Sciences Building
Research Wing
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Phone	+44 (0)2476 968618
Email	damian.griffin@warwick.ac.uk

Study information

Study design	Observer blind randomised controlled 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	Improved functional outcome in heel fracture with surgical treatment versus non-operative care: a randomised controlled trial
Study objectives	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(s)	Oxfordshire REC A, 24/05/2006, ref: 06/Q1604/58
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2006
Completion date	30/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	150; 75 in each group
Key inclusion criteria	1. Closed displaced intra-articular fractures of the calcaneus 2. Aged over 18 years, no upper age limit, either sex
Key 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
Date of first enrolment	01/06/2006
Date of final enrolment	30/11/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Warwick Medical School

Coventry
CV2 2DX
United Kingdom

Sponsor information

University Hospitals Coventry and Warwickshire NHS Trust (UK)
Hospital/treatment centre

University Hospital
Walsgrave
Coventry
CV2 2DX
England
United Kingdom

Phone	+44 (0)2476 602020
Email	info@uhcw.nhs.uk
Website	http://www.uhcw.nhs.uk/
"ROR"	https://ror.org/025n38288

Funders

Funder type

Charity

Arthritis Research Campaign (ARC) (UK) (ref: 15964)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	24/07/2014		Yes	No