Condition category
Musculoskeletal Diseases
Date applied
07/02/2006
Date assigned
22/02/2006
Last edited
28/07/2014
Prospective/Retrospective
Prospectively 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

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

http://www.uhcw.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes