Childhood displaced Salter Harris-II fractures of the distal tibial physis Musculoskeletal Diseases
Conditions
Interventions
The proposed project is a two-phased study. Phase 1 (internal pilot) will confirm the expected rate of recruitment and pilot data collection procedures in a large-scale multi-centre RCT. Phase 2 is th
in others the child may be discharged to an early appointment in the fracture clinic. Owing to the nature of the condition and treatment pathways, the study will be introduced to the patient at the po
Sponsors
Alder Hey Children's NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 8 to 15 years old inclusive 2. There is radiographic evidence of a displaced fracture of the distal tibia involving the physis and metaphysis (Salter Harris II); with or without a corresponding fibula fracture 3. The treating clinician believes that they may benefit from surgical reduction +/- fixation
Exclusion criteria
Exclusion criteria: 1. The injury is more than 7 days old 2. The fracture is open 3. They have an intra-articular fracture that requires fixation to restore the joint surface 4. They have any other contralateral (Opposite-sided) ankle fracture/injury 5. There is evidence that the patient and/or parent/guardian would be unable to adhere to trial procedures or complete follow-up 6. The patient has previously been enrolled on the ODD SOCKS Study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether children treated with surgical correction have improved function compared with children treated with conservative care measured using the PROMIS Mobility questionnaire, at 24 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be assessed during the first 2-years post-randomisation between surgical reduction and conservative treatment: 1. Function measured using the PROMIS-Mobility Score at 6 weeks, 3, 6 and 12 months post-randomisation 2. Pain scores measured using the Wong-Baker faces pain rating scale at 6 weeks, 3, 6, 12 and 24 months post-randomisation 3. Quality of life measured using EQ-5D-Y at 6 weeks, 3, 6, 12 and 24 months post-randomisation 4. Complication rate measured using data collected in medical records at 6/8 weeks, 12 and 24 months post-randomisation 5. Satisfaction with cosmetic appearance of the leg measured using the Visual Analogue Scale (VAS) of cosmesis at 3, 12 and 24 months post-randomisation 6. Satisfaction with the treatment received measured using a Likert Scale at 3, 12 and 24 months post-randomisation 7. Child educational participation recording educational absences measured using a parent-reported questionnaire at 6 weeks, 3, 6, 12 and 24 months post-randomisation 8. Leg Length Measurement measured using the ‘Tape Measurement Method’ by a clinician at 12 and 24 months 9. Angular deformity and PPC (growth arrest) measured using radiographic images 24 months post-randomisation 10. Resource use measured using a bespoke electronic resource use questionnaire, and parental absence from work at 6 weeks, 3, 6, 12 and 24 months post-randomisation | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactKinzah Abbasi
Outcome results
None listed