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

Completed

• Conditions: Calcaneal fracture; Musculoskeletal Diseases

• Registration Number: ISRCTN37188541
• Lead Sponsor: niversity Hospitals Coventry and Warwickshire NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Closed displaced intra-articular fractures of the calcaneus
2. Aged over 18 years, no upper age limit, either sex

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)