| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN37188541 |
| Date ISRCTN assigned | 22/02/2006 |
| Local reference number(s) | 15964 |
| Public title | UK heel fracture trial |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Calcaneal fracture |
| Study hypothesis | Surgical treatment leads to improved functional outcome compared with non-operative care |
| Design/methodology | Observer blind, randomised controlled trial |
| Research ethics review | Ethical approval not yet received |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Closed displaced intra-articular fractures of the calcaneus |
| Participants - exclusion criteria | 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 |
| Patient information material |
|
| Anticipated start date | 01/01/2006 |
| Anticipated end date | 30/06/2010 |
| Status of trial | Ongoing |
| Target number of participants | 150; 75 in each group |
| Interventions | 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) | 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 15964 |
| Sponsor name | University Hospitals Coventry and Warwickshire NHS Trust (UK) |
| Sponsor details | University Hospital
Walsgrave
Coventry
United Kingdom
CV2 2DX |
| Sponsor telephone | +44 (0)2476 602020 |
| Sponsor email | info@uhcw.nhs.uk |
| Contact name | Prof Damian Griffin |
| Contact details | Warwick Medical School
Clinical Sciences Building
Research Wing
Clifford Bridge road
Coventry
United Kingdom
CV2 2DX |
| Contact telephone | +44 (0)2476 968618 |
| Contact fax | +44 (0)2476 968617 |
| Contact email | damian.griffin@warwick.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN37188541 |
| Date last extracted from ISRCTN register | 17/04/2008 |
