KFORT: Knee fix or replacement trial

KFORT - Knee Fix or Replacement Trial - A feasibility study comparing fixation vs replacement in elderly patients sustaining a distal femoral fracture

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16109266

Enrollment

Registered

2015-11-05

Start date

2015-10-23

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Injuries and emergencies, Musculoskeletal disorders, Ageing

Interventions

Participants are randomly allocated to one of two treatments. Open Reduction and Internal Fixation (ORIF) Group: The patient will undergo fixation, performed by an appropriately train

and will allow us to compare the treatments at the end of the study.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 65 years or over 2. Informed consent to participate or an agreement from a personal or nominated consultee 3. Presence of a closed distal femoral fracture 4. Patient considered suitable for distal femoral replacement 5. Patient is able to complete trial procedures

Exclusion criteria

Exclusion criteria: 1. Open fracture 2. Previous ipsilateral (same side as fracture) knee replacement 3. Patient is unfit for anaesthesia

Design outcomes

Primary

Measure	Time frame
Patient reported outcome score is measured using the EQ-5D-5L questionnaire 6 months post injury.	—

Secondary

Measure	Time frame
1. Patient reported health outcome is measured using the EQ- 5D- 5L questionnaire at baseline, 6 weeks and 9 months post-surgery 2. Patient reported function and pain outcome is measured using the Oxford Knee score (OKS) at baseline, 6 weeks, 6 months and 9 months post-surgery 3. Patient reported functional outcome is measured using the Disability Rating Index (DRI) at baseline, 6 weeks, 6 months and 9 months post-surgery 4. Adverse events of special surgical interest experienced by the patient will be recorded during surgery and the course of the trial 5. Standard anterior-posterior and lateral radiographs of the knee including the distal femur are taken at baseline, 6 weeks and 9 months after surgery 6. Knee range of motion for knee extension and flexion is measured using a goniometer at 6 weeks and 9 months post-surgery 7. Health economic data is determined by measuring length of hospital stay, complication rates, resource use and societal costs during the course of the trial	—

Measure

Time frame

1. Patient reported health outcome is measured using the EQ- 5D- 5L questionnaire at baseline, 6 weeks and 9 months post-surgery 2. Patient reported function and pain outcome is measured using the Oxford Knee score (OKS) at baseline, 6 weeks, 6 months and 9 months post-surgery 3. Patient reported functional outcome is measured using the Disability Rating Index (DRI) at baseline, 6 weeks, 6 months and 9 months post-surgery 4. Adverse events of special surgical interest experienced by the patient will be recorded during surgery and the course of the trial 5. Standard anterior-posterior and lateral radiographs of the knee including the distal femur are taken at baseline, 6 weeks and 9 months after surgery 6. Knee range of motion for knee extension and flexion is measured using a goniometer at 6 weeks and 9 months post-surgery 7. Health economic data is determined by measuring length of hospital stay, complication rates, resource use and societal costs during the course of the trial

—

Countries

United Kingdom

Contacts

Public ContactJustyna Romanik

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026

KFORT:­ Knee fix or replacement trial