Injuries to the knee and lower leg Injury, Occupational Diseases, Poisoning Injuries to the knee and lower leg
Conditions
Interventions
Participants will be randomly allocated into one of two techniques for the operative fixation of closed type C pilon fractures:
Internal plate fixation
The ‘locking’ plate is inserted at the distal e
Sponsors
Hull and East Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 05/03/2019: 1. Patients aged 16 years or older 2. With a closed intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 – C1, C2 and C3 (complete articular). This includes patients with a bi-lateral pilon fracture and who have polytrauma. 3. Where the treating surgeon believes the patient will benefit from surgical fixation Previous inclusion criteria: 1. Patients aged 16 years or older 2. With a closed unilateral intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 – C1, C2 and C3 (complete articular). Only unilateral fractures are included since problems may occur in rehabilitation with bilateral fractures which may compromise outcomes 3. Where the treating surgeon believes the patient will benefit from surgical fixation
Exclusion criteria
Exclusion criteria: 1. More than 21 days since injury 2. Previous failed fixation 3. Pathologic fracture 4. Pre-existing (pre-injury) skin condition which precludes open surgery 5. Patient is/would be unable to understand instructions for treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient's own rating of their disability specifically related to the lower limb, assessed using the Disability Rating Index (DRI) at baseline, 3, 6, 12 and 24 months follow-up post-randomisation. The DRI is a validated patient-reported outcome measure questionnaire. It consists of a 12-item Visual Analogue Scale questionnaire. The DRI has been proven to be a robust, practical clinical and research instrument with good responsiveness and acceptability for assessment of disability caused by impairment in the lower limb. The baseline assessment will ask participants about their functioning before their injury and before their surgery. Twelve months after randomisation has been chosen to be the primary endpoint to allow the interventions and co treatment interventions to be delivered and the majority of complications to be treated. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Olerud and Molander Ankle Score (OMAS) collected at baseline, 3, 6, 12 and 24 months follow-up 2. Patient health related quality of life, assessed using the EQ5D-5L generic and health economic self-complete patient-reported outcome measure. This will be collected twice at baseline: i.e. once to assess patient health related quality of life on the day (after the injury) and once with regard to patient health related quality of life during the week before injury; then once each at 3, 6, 12 and 24 months 3. Complications: Data on all further surgical procedures and other complications, e.g. deep wound infection (using Centres for Disease Control and Prevention definition), superficial infection, pin site infection (defined using the ‘Good, Bad and Ugly’ pin site grading system), rehospitalisation, blood clots, wound dehiscence, septic arthritis, secondary interventions for non-union and all other secondary procedures will be collected at 3, 6, 12 and 24 months 4. Non-union, mal-union and secondary arthritis. Non-union will be defined as inability to heal as confirmed on x rays/CT scan or as secondary intervention for failure to heal. Mal-union is defined by a standard measurement based on Dror Paley's technique, undertaken using final radiographs at 12 months. Secondary arthritis in the ankle will be assessed using the Kellgren and Laurence scale 5. Resource use and work impact: Data on resource use and work impact will be collected to inform the economic evaluation (e.g. length of hospital stay, rehospitalisation and return to work). This data will be gathered at 3, 6, 12 and 24 months 6. Patient preference for treatment: Data on patient preferences will be collected at baseline and 12 months 7. Transition question: To assist interpretation of findings, patients will be asked at the 12-month follow-up time-point whether compared with when they initially sustained the pilon fracture one year previously, how their ankle is currently | — |
Countries
Australia, England, Northern Ireland, Scotland, South Africa, United Kingdom, Wales
Outcome results
None listed