Condition category
Musculoskeletal Diseases
Date applied
05/11/2015
Date assigned
05/11/2015
Last edited
26/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The knee is the largest weight-bearing joint in the body, where the shin bone (tibia) and thigh bone (femur) meet. As we get older our bones naturally weaken, and so the elderly are particularly vulnerable to knee pain and injury. Every year, about 5,000-7,000 people over the age of 65 in the UK suffer from distal femur fractures (a fracture at the end of the thigh bone, just above the knee joint). In most cases, the main treatment offered is surgical fixation. This is an operation in which the broken pieces of bone are lined up, and held in place with wires, screws or metal plates. It is more effective than simply wearing a cast, as it ensures that the bones heal in the correct position. In order for this treatment to be work properly, patients need to rest and not put any weight on their leg. This can be very difficult, as in particularly elderly patients this process can be very slow due to their weakened bones (osteopenia). An alternative treatment is distal femoral replacement (DFR) surgery. This operation involves removing the section of broken bone and replacing it with man-made implant made from metal or plastic (prosthesis). It has the advantage of a very rapid recovery, and patients are able to put weight on their leg again almost immediately. This type of operation is more common in younger people who have suffered a serious injury, such as a car accident, and so more research is needed to find out if it is a good alternative to surgical fixation in the elderly. The aim of this study is to look at the effects of having DFR surgery or surgical fixation on the recovery of elderly patients with a distal femur fracture.

Who can participate?
Adults over 65 years of age with a distal femur fracture, who are suitable for a DFR surgery.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive distal femoral replacement surgery. Participants in the second group have an operation which involves surgical fixation of the fracture. The length of time that the participants have to stay in hospital after their surgery is then recorded. Information about the patients (health related questionnaires, complications, length of hospital stay and X-ray pictures) is collected before surgical treatment and at 6 weeks, 6 months and 9 months after their surgery in order to compare the effectiveness of the two treatments.

What are the possible benefits and risks of participating?
Participants will benefit from good continuity of care, as they will see a dedicated consultant and research nurse throughout their involvement in the study. Risks of participating include the general risks of undergoing surgery, and being sedated with general anaesthetic.

Where is the study run from?
Addenbrookes Hospital and six other NHS hospitals in England (UK)

When is the study starting and how long is it expected to run for?
October 2015 to April 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Miss Tapiwa Tungamirai

Trial website

Contact information

Type

Public

Primary contact

Miss Tapiwa Tungamirai

ORCID ID

Contact details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19845

Study information

Scientific title

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

Acronym

KFORT

Study hypothesis

The aim of this study is to compare surgical fixation versus replacement in patients 65 years and older.

Ethics approval

First Medical Research Ethics Committee, 04/08/2015, ref: 15/WM/0206

Study design

Multi-centre randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Injuries and emergencies, Musculoskeletal disorders, Ageing; Subtopic: Injuries and Emergencies (all Subtopics), Musculoskeletal (all Subtopics), Ageing; Disease: Injuries and Emergencies, Musculoskeletal, All Ageing

Intervention

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 trained surgical team. Specific reduction technique, surgical approach and implant selection will not be fixed by the study, but the surgeons must comply with recognised concepts of distal femur fracture fragment reduction and fixation techniques.

Distal Femoral Replacement (DFR) Group: The patient will undergo a DFR performed by an appropriately trained surgical team and complying with recognised concepts of distal femoral replacement.

Information about the patients will be collected 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 X­ray pictures; and will allow us to compare the treatments at the end of the study.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/11/2014

Overall trial end date

23/10/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 46; UK Sample Size: 46

Participant exclusion criteria

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

Recruitment start date

23/10/2015

Recruitment end date

23/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

University Hospital Coventry & Warwickshire
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Ipswitch Hosptial
Heath Road
Ipswich
IP4 5PD
United Kingdom

Trial participating centre

Southmead Hospital
Southmead Road
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Trial participating centre

The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

Stepping Hill Hospital
Poplar Grove Hazel Grove
Stockport
SK2 7JE
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust

Sponsor details

Clinical Pharamacology Unit
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of the feasibility study report in a high impact orthopaedic journal. The results will also be submitted for publication and a report will be disseminated through other peer-reviewed journals, conference presentations and through local mechanisms at all participating centres. A short plain English report for patients and/or their carers, will be co-written by the PPI collaborators.

Intention to publish date

30/06/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes