Tibial plateau fracture Injury, Occupational Diseases, Poisoning Tibial plateau fracture
Conditions
Interventions
Participants will be randomly allocated using unstratified block randomisation with varying block sizes into 2 arms, with 15-20 patients in each arm. Participants in both groups will receive the same
Sponsors
university of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Skeletally mature 3. Acute unilateral closed tibia plateau fractures as primary injury 4. Willing and able to provide informed consent and participate in all study activities and visit schedule 5. Ambulatory prior to injury
Exclusion criteria
Exclusion criteria: 1. Open/compound tibial plateau fracture 2. Fracture type 41 C according to Muller AO classification 3. Multi-segmental fracture (more than one fracture site within tibia) 4. Polytrauma (Injury Severity Score of 17 or more) 5. Prior or concomitant illnesses that may affect healing or outcome 6. Exposure to drugs that can affect the bone metabolic state within the past 3 months 7. Receiving chemotherapy, radiation treatment or immunosuppressant drugs 8. Currently enrolled in any other study that may impact on the results of the present study 9. Resident outside of Leeds 10. Pregnant or breastfeeding 11. If female: not currently using and not willing to use an effective form of contraception for 12 months post-surgery 12. Metal allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Quality of life, assessed at the baseline and at week 6, 12, 24 and 52, using: 1.1 12-item Short Form Health Survey (SF-12) 1.2. EuroQol-5D (EQ-5D) 2. Pain whilst weight-bearing, assessed using the Numeric Pain Rating Scale (NPRS) at the baseline and at week 2, 6, 12, 24 and 52 3. Patient mobilisation, assessed using a timed "up-and-go" test (TUG) at weeks 6 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to bone healing, assessed using: 1.1. Clinical measures: 1.1.1. Painless full weight bearing 1.1.2. Functional IndeX in Trauma (FIX-IT) score 1.2. Radiological measures - Radiographic Union Scale in Tibial fractures (RUST) scale with a CT scan 2. Proportion of participants healed at 3 and 6 months after surgery 3. Rate of surgical re-intervention at 6 months after surgery 4. Incidence of loss of reduction, secondary collapse or further surgical intervention at the 6 month follow up | — |
Countries
England, United Kingdom
Outcome results
None listed