Toddler's fractures - non-displaced spiral fractures of the tibia Musculoskeletal Diseases
Conditions
Interventions
Participants will be randomised 1:1, using an online system provided by the Sheffield CTRU, to non-immobilisation management or immobilisation. Patients randomised to 'immobilisation' should receive a
Sponsors
Sheffield Children’s NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
9 Months to 3 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 23/06/2025: 1. Children aged from 9 months to their 4th birthday at the time of initial presentation to the hospital 2. Clinically suspected or confirmed toddler’s fracture of the tibia as determined by standard guidelines at the recruiting site. Previous participant inclusion criteria: 1. Children aged 9 months - 3 years 2. Attending ED or Fracture clinic within 72 hours of injury 3. Radiologically confirmed toddler’s fracture of the tibia on x-ray, with displacement <2mm at the apex of the deformity including spiral/oblique fractures, transverse or buckle fractures, with or without a non-displaced fibula fracture; OR, a clinically suspected toddler’s fracture, as determined by standard guidelines at the recruiting site.
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 23/06/2025: 1. Suspected non-accidental injury requiring further imaging or investigation 2. Associated displaced fibula fracture 3. Comminuted/complex fracture patterns of the tibia 4. Physeal injuries of the tibia 5. Multiple fractures 6. Metabolic bone disease 7. Congenital anomalies involving the lower limb and foot (limb deficiencies) 8. Has previously participated in the ToTs Study Previous participant exclusion criteria: 1. Non-accidental injury requiring further imaging or investigation 2. Multiple injuries 3. Associated displaced fibula fracture 4. Comminuted fracture patterns 5. Physeal injuries of the tibia 6. Metabolic bone disease 7. Congenital anomalies involving the lower limb and foot (limb deficiencies)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain is measured using the Face, Legs, Activity, Cry, Consolability (FLACC) behavioural pain assessment scale (or revised FLACC for children with cognitive impairment) at baseline, 72 hours, day 7 (primary) and day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 23/06/2025: 1. Planned and unplanned attendances to ED, Plaster Room or Fracture clinics measured using data collected in medical notes at one timepoint 2. Additional use of plain radiograph imaging measured using data collected in medical notes at one timepoint 3. Recovery of mobility (time to weight bear) measured using proxy reporting on days 7 and 28 4. Use of additional treatments measured using data collected in medical notes at one timepoint 5. Requirement for oral analgesia measured using proxy reporting at day 7 6. Resource use at 28 days and contact with other NHS services measured using proxy reporting 7. Satisfaction with allocated treatment measured using a parent-completed Likert scale at 28 days 8. Complications, including: a) Pressure ulcers resulting from the use of devices designed and applied for diagnostic or therapeutic purposes category 1-4; b) Fracture displacement requiring further treatment measured using data collected in medical notes at one timepoint Previous secondary outcome measures: 1. Planned and unplanned attendances to ED, Plaster Room, GP or Fracture clinics measured using data collected in medical notes at one timepoint 2. Additional use of plain radiograph imaging measured using data collected in medical notes at one timepoint 3. Recovery of mobility (time to weight bear) measured using proxy reporting on days 7 and 28 4. Use of additional treatments measured using data collected in medical notes at one timepoint 5. Requirement for oral analgesia measured using proxy reporting at day 7 6. Resource use at 28 days and contact with other NHS services measured using proxy reporting 7. Satisfaction with allocated treatment measured using a parent-completed Likert scale at 28 days 8. Complications, including: a) Pressure ulcers resulting from the use of devices designed and applied for diagnostic or therapeutic purposes category 1-4; b) Fracture displacement requiring further treatment mea | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactMuniba Aslam
Outcome results
None listed