Management of ankle fractures in childre
Not Applicable
- Conditions
- Injuries to the knee and lower legMusculoskeletal Diseases
- Registration Number
- ISRCTN29688616
- Lead Sponsor
- ottingham University Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 103
Inclusion Criteria
1. Aged 5-15 years inclusive
2. Proven low-risk ankle fracture on x-ray: minimally displaced or undisplaced fibular fracture
3. A clinical undisplaced fracture which fulfils the Ottawa criteria:
3.1. A history of trauma
3.2. Tenderness at the posterior edge of the lateral malleolus
3.3. Unable to weight bear for more than 4 steps
3.4. No alternative cause of pain identified on x-ray
Exclusion Criteria
1. Additional injuries
2. Injury is more than 7 days old at recruitment
3. Current medical condition that prevents the use of any of the treatments (e.g. dermatitis, vasculitis, congenital foot or ankle deformities)
4. In conjunction with their parents are unable to complete the outcome measures chosen in English
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility outcome measures:<br>1. Recruitment rates compared to site screening logs as the number of eligible participants who are randomized in the study<br>2. Retention rates, drop out and crossovers as a proportion of recruited patients who complete the study regime<br>3. Adherence to treatments measured using a patient diary for 14 days of treatment<br>4. Trial experience and qualitative feedback from participants collected through structured interviews with a sample of participants at 12-24 weeks
- Secondary Outcome Measures
Name Time Method 1. Physical function measured by ASK-P, PROMIS Mobility at 6 and 12 weeks<br>2. Quality of life measured by EQ-5D-Y and PedsQL4.0 at 6 and 12 weeks<br>3. Global rating of change score at 6 and 12 weeks<br>4. Daily pain scores measured using a patient diary for 14 days of treatment<br>5. Re-injury rates measured using a self-reported questionnaire at 6 and 12 weeks<br>6. Complications measured using a self-reported questionnaire at 6 and 12 weeks