Is Casting of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia?

Condition(s) studied

Investigational drug(s) / intervention(s)

Non-surgical treatment: If allocated to non-surgical group, cast optimization in the outpatient clinic may be necessary if the cast from the emergency room is considered insufficient.

Surgical treatment: Closed reduction with or without fixation

Study summary

Treatment of displaced distal forearm fractures (DFF) in children have traditionally been closed reduction and pin fixation, although they might heal and remodel without manipulation, with no functional impairment. No randomized controlled trials (RCTs) have been published comparing the patient-reported functional outcome after non-surgical and surgical treatment of displaced DFF in children.

This is a multicentre RCT. The aim of the trial is to investigate the patient-reported functional outcome after non-surgical treatment of displaced distal forearm fractures (DFF) in children. We will include 44 children aged 4-10 years with a displaced DFF. They will be offered inclusion, if the on-duty orthopedic surgeon finds indication for surgical intervention. If the parents/guardians consent to participate, the children will be allocated equally to non-surgical treatment (intervention) or surgical treatment of surgeon's choice (comparator). We will follow the children during one year, where they will be seen after 4 weeks, 3, 6 and 12 months. The primary outcome is the between-group difference in 12 months Quick Disabilities Arm Shoulder and Hand (QuickDASH) score.

Eligibility

Primary outcome measure(s)

• QuickDASH — 12 months
  Reporting of disability experienced and monitoring changes in symptoms and function over time. The patient (with help by parents if the patient is too young to self-report) rates each item according to the perceived degree of severity using a 5-point Likert Scale. Then, the overall score is transformed to a score between 0 and 100 (0 = no disability, 100 = maximum disability) according to the algorithm \[(sum of responses N/N)-1\]\*25, where N is equal to the number of responses.

Trial sites (4)

More Zealand University Hospital trials in Denmark

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