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Updated: Jan 4, 2026

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Knee Fix or Replace Trial (KFORT): a randomized controlled feasibility study.

Peter D Hull1, Daud T S Chou1, Sophie Lewis2

  • 1Orthopaedic Trauma Unit, Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.

The Bone & Joint Journal
|November 2, 2019
PubMed
Summary
This summary is machine-generated.

A full-scale trial comparing internal fixation and distal femoral replacement for elderly patients with distal femoral fractures is not feasible in the UK. An international multicentre trial may be possible, requiring 1400 patients and 234 centers.

Keywords:
Distal femoral fractureDistal femoral replacementInternal fracture fixationOlder patient

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Area of Science:

  • Orthopedic surgery
  • Trauma surgery
  • Clinical trial methodology

Background:

  • Distal femoral fractures are common in older patients.
  • Treatment options include internal fixation and distal femoral replacement (DFR).
  • A definitive randomized controlled trial (RCT) is needed to compare these treatments.

Purpose of the Study:

  • To assess the feasibility of a full-scale RCT comparing internal fixation and DFR for distal femoral fractures in older patients.
  • To gather data on patient and clinician willingness to participate, recruitment rates, and data capture.
  • To estimate sample size and cost for a powered RCT.

Main Methods:

  • A pilot study was conducted across seven UK centers.
  • Patients aged over 65 with distal femoral fractures, suitable for either treatment, were recruited.
  • Outcome measures included participation rates, loss to follow-up, data completeness, cost, and the EuroQol five-dimensional index (EQ-5D) at six months.

Main Results:

  • Only 23 of 36 eligible patients were randomized, with significant withdrawal and mortality rates.
  • A full-scale RCT would require 1400 patients recruited from 234 centers over three years.
  • The mean cost of DFR implants was higher than other treatment components.

Conclusions:

  • Conducting a full-scale RCT in the UK is not feasible due to recruitment and logistical challenges.
  • An international multicentre trial may be feasible and could provide valuable data.
  • The study provides guidance on sample size, power, and anticipated challenges for future trials.