KFORT: Knee fix or replacement trial
| ISRCTN | ISRCTN16109266 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16109266 |
| Secondary identifying numbers | 19845 |
- Submission date
- 05/11/2015
- Registration date
- 05/11/2015
- Last edited
- 04/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Study information
| Study design | Multi-centre randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | KFORT - Knee Fix or Replacement Trial - A feasibility study comparing fixation vs replacement in elderly patients sustaining a distal femoral fracture |
| Study acronym | KFORT |
| Study objectives | The aim of this study is to compare surgical fixation versus replacement in patients 65 years and older. |
| Ethics approval(s) | First Medical Research Ethics Committee, 04/08/2015, ref: 15/WM/0206 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2014 |
| Completion date | 23/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 46; UK Sample Size: 46 |
| Total final enrolment | 24 |
| Key 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 |
| Key exclusion criteria | 1. Open fracture 2. Previous ipsilateral (same side as fracture) knee replacement 3. Patient is unfit for anaesthesia |
| Date of first enrolment | 23/10/2015 |
| Date of final enrolment | 23/04/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Cambridge
CB2 0QQ
United Kingdom
Coventry
CV2 2DX
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Bristol
BS10 5NB
United Kingdom
Exeter
EX2 5DW
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Hazel Grove
Stockport
SK2 7JE
United Kingdom
Sponsor information
Hospital/treatment centre
Clinical Pharamacology Unit
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
"ROR" |
https://ror.org/04v54gj93 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2019 | 04/11/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/11/2019: Publication reference added.
09/10/2019: The total final enrolment was added.
19/04/2017: The study contact has been changed from Tapiwa Tungamirai to Justyna Romanik.
