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NCT05736068
Is CASTING of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia?
Conditions: Distal Forearm Fracture, Distal Radius Fracture
Sex: All
Ages: 4 Years – 10 Years
Phase: NA
Enrollment: 44
Sponsor: Zealand University Hospital
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 Criteria
Inclusion Criteria:Children 4-10 years of age with open physesFractures in the distal metaphyseal radius (with or without concomitant ulna fracture), including extraarticular physeal fractures (SH I-II)Overriding fracturesAngulated fractures of 20-40°The on-duty surgeon finds reduction under anesthesia with or without fixation indicatedExclusion Criteria:Open fracturesNerve or vascular affectionAll intraarticular fractures including SH III-VUlnar physeal fracturesPolytraumaConcomitant ipsi- or contralateral upper extremity fractures (except distal ulna fracture)Pathologic fracturesThe injury is >7 days oldOther conditions that may affect bone healing
Source: ClinicalTrials.gov (NCT05736068). StuddyBuddy aggregates publicly available trial information.