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02 September 2010
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| [ Print-friendly version ] |
| UK heel fracture trial: surgical treatment versus non-operative care |
| ISRCTN | ISRCTN37188541 |
| ClinicalTrials.gov identifier | |
| Public title | UK heel fracture trial: surgical treatment versus non-operative care |
| Scientific title | Improved functional outcome in heel fracture with surgical treatment versus non-operative care: a randomised controlled trial |
| Acronym | N/A |
| Serial number at source | 15964 |
| 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 | Added 09/02/2009: Oxfordshire REC A gave approval on the 24th May 2006 (ref: 06/Q1604/58) |
| Study design | Observer blind randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Calcaneal fracture |
| Participants - inclusion criteria |
1. Closed displaced intra-articular fractures of the calcaneus
2. Aged over 18 years, no upper age limit, either sex |
| Participants - 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 |
| Anticipated start date | 01/06/2006 |
| Anticipated end date | 30/11/2010 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 150; 75 in each group |
| Interventions |
Intervention: open reduction and internal fixation by extensile lateral approach
Control: non-surgical treatment with elevation and ice followed by spintage and early mobilisation |
| Primary outcome measure(s) | 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 measure(s) |
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. |
| Sources of funding | Arthritis Research Campaign (ARC) (UK) (ref: 15964) |
| Trial website | |
| Publications | |
| Contact name | Prof Damian Griffin |
| Address |
Warwick Medical School
Clinical Sciences Building Research Wing Clifford Bridge Road |
| City/town | Coventry |
| Zip/Postcode | CV2 2DX |
| Country | United Kingdom |
| Tel | +44 (0)2476 968618 |
| Fax | +44 (0)2476 968617 |
| damian.griffin@warwick.ac.uk | |
| Sponsor | University Hospitals Coventry and Warwickshire NHS Trust (UK) |
| Address |
University Hospital
Walsgrave |
| City/town | Coventry |
| Zip/Postcode | CV2 2DX |
| Country | United Kingdom |
| Tel | +44 (0)2476 602020 |
| info@uhcw.nhs.uk | |
| Sponsor website: | http://www.uhcw.nhs.uk/ |
| Date applied | 07/02/2006 |
| Last edited | 11/02/2009 |
| Date ISRCTN assigned | 22/02/2006 |
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