KFORT - Knee Fix or Replacement Trial
Research type
Research Study
Full title
KFORT - Knee Fix or Replacement Trial. A feasibility study comparing fixation vs replacement in elderly patients sustaining a distal femoral fracture.
IRAS ID
153566
Contact name
Peter Hull
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 2 days
Research summary
Approximately 5-7,000 elderly people break their distal femur (lower end of the thigh bone) each year in the UK and most will undergo surgical fixation to fix the bone pieces together. It is recognised that unsatisfactory outcomes are common for this patient group; the operation is challenging, as the bones are often fragile and broken into many pieces, and patients are often instructed to keep weight off their injured leg for a considerable time to enable bone healing. As many will be too frail or confused to use crutches, patients can potentially remain bed bound until the fracture heals. An alternative to fixing the fracture is to remove the broken bone section and replace this with a complex form of knee replacement – a distal femoral replacement. This type of surgery avoids the problem of fixing fragile bone parts and patients can start walking on their injured leg immediately. However there are risks of infection or the replacement becoming loose. Currently we do not know which treatment is best. We are therefore proposing to undertake a multicentre study in England of surgical fixation versus replacement in patients 65 years and older.
Patients who are eligible for the study and have agreed to participate or have been deemed to have no objection in taking part by a consultee (for those lacking capacity), will be randomly allocated one of the two treatments. 23 patients will receive surgical fixation and 23 patients will receive surgical replacement. We will collect information about the patients before treatment and at 6 weeks, 6 months and 9 months after their surgery within normal NHS hospital settings. This information includes health related questionnaires, complications, length of stay and X-ray pictures; and will allow us to compare the treatments at the end of the study.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
15/WM/0206
Date of REC Opinion
4 Aug 2015
REC opinion
Favourable Opinion