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 Justyna Romanik
Trial website
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list