Title: KFORT – Knee Fix or Replacement TrialA feasibility study comparing fixation vs replacement in elderly patients sustaining a distal femoral fracture
Funder: Department of Health and Social Care

Abstract: Background There are between 5-7,000 distal femoral fractures (DFF) occurring in the UK in elderly people each year(6). This is a vulnerable patient group; pre-existing medical complications are common(3-5) and a recent study of elderly patients with similar fractures found that approximately 30% have cognitive impairments such as dementia(2). The impact of this injury, surgery and hospital stay on an elderly person means that many will never return to their previous level of function and independence. The one year mortality rate from this injury is 25%(3) and using hip fracture data, we estimate that the annual cost to the NHS and society is over &pound;200 million (7). DFF occur in the same population group as hip fractures. NICE guidelines for the management of hip fractures state that patients should be allowed to fully weight bear immediately following surgery(7). No such guidance exists for DFF and current evidence is inconclusive and insufficient to inform clinical practice about the best management for elderly patients, as stated in a recent Cochrane review(8). Surgical fixation is the mainstay of treatment; however in elderly patients complications are common(9&ndash;13). Osteoporotic bone is difficult to adequately fix to enable immediate weight bearing and over 90% of patients are not allowed to weight bear following DFF fixation surgery(5). This is difficult for elderly patients, especially those who are frail or cognitively impaired as they are unable to hop on one leg, thereby restricting their mobility and prolonging their dependence on care. An alternative to fixation is to remove the broken bone and replace it with a complex form of a knee replacement - A distal femoral replacement (DFR) Replacement surgery is gaining popularity in some institutions as it allows patients to fully weight bear immediately and potentially rehabilitate faster. There is however a significant difference in the surgical device costs. Fixation devices cost around &pound;1,200 vs &pound;9,000 for the DFR. Our aim is to assess the feasibility of performing a larger scale trial and if found to be feasible we will be applying for HTA funding Our objectives are to measure: Willingness of patients to participate and clinicians to recruit participants Drop out rates Ability to capture all data Estimates of standard deviation to inform the sample size calculation for the main trial Completion rates and the main cost-drivers, to inform the decision as to how costs and benefits should be measured in a definitive trial Plan of investigation 5 sites have agreed to participate. 3 Teaching Hospitals and 2 District General Hospitals to assess the feasibility and whether study results can be generalised across centres. Inclusion criteria Patients aged 65 years or over, including those with cognitive impairment Sustaining a fracture which involves the distal femur, considered by the treating surgeon to be potentially suitable for a distal femoral replacement. All such patients could also be treated by fixation. Eligible and appropriately consented patients will be randomised to fixation or replacement. Patient reported outcome measures will be collected using validated questionnaires, namely EQ5D, Disability Rating Index (DRI) and the Oxford Knee Score (OKS). We will record complications, items of resource use and xray images. Data will be collected at baseline, 6 weeks, 6 and 9 months post-injury. The primary outcome measure will be EQ-5D, this has been chosen as it is validated for completion by proxy (27) if patients are cognitively impaired and is validated for use as an outcome measure for hip fracture patients (a similar patient group) (28) Potential benefits If feasible, a definitive trial will assess the clinical and cost effectiveness of the two surgical treatments.

Lay abstract: Approximately 5-7,000 elderly people break the end of their thigh bone each year in the UK and most will undergo surgery to fix the bone pieces together. It is well 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 must then keep off their injured leg for a considerable time to enable bone healing. As many will be too frail or confused to use crutches, they will either remain bed bound or put weight through the injured leg which can break the metalwork or cause the bone pieces to fall apart. An alternative to fixing the fracture is to remove the broken bone section and replace this with a complex form of knee replacement &ndash; a distal femoral replacement. This type of surgery avoids the problem of fixing fragile bone parts and most positively, patients can start walking on their injured leg immediately. Currently we do not know which treatment is the best. We are therefore proposing to undertake a randomised study of surgical fixation versus replacement in elderly patients. Patients who are eligible for the study and have agreed to participate will be randomly allocated one of the two treatments. 23 patients will receive surgical fixation and 23 surgical replacement. Patients who have altered capacity, through conditions such as dementia, will be eligible for inclusion within the study and we will work closely with their carers. We will collect information from patients about their health before they receive their allocated treatment and collect more information (including complications, health related questionnaires, length of stay and x-ray pictures) at 6 weeks, 6 months and 9 months after their surgery. This will allow us to compare the treatments at the end of the study.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS