Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK
Perry DC, Achten J, Knight R, et al. Lancet. 2022;400(10345):39-47.
SUMMARY:
Although buckle fractures are the most common fracture type in children, substantial practice variation exists among clinicians, and national and international guidelines, regarding both management (ranging from cast to splint to no treatment) and the need for clinical follow-up.
A Cochrane review on the topic from 2018 identified 10 trials including 695 children, and concluded that recovery was comparable for all care provided, but the overall quality of evidence was low.
Thus, the optimal practice remains unclear, and moving away from the desire to immobilize broken bones has been slow: practice patterns have not changed substantially over the past few decades.
Interestingly, the authors of this trial sought to compare rigid immobilization with no treatment; however, in pretrial focus groups, families reported that they considered no treatment an unacceptable option.
The Forearm Fracture Recovery in Children Evaluation (FORCE) trial was a multicenter, randomized, controlled equivalence trial conducted in 23 emergency departments in the U.K.
Children 4 to 15 years of age with a radiologically confirmed acute torus fracture of the distal radius (excluding those with additional wrist fractures and greenstick fractures) were randomized to receiving either a bandage (generally a roll of gauze) or rigid immobilization via either a rigid splint or a plaster cast, at the discretion of the treating physician. Most were treated with a removable wrist splint.
The primary outcome was pain at 3 days, and secondary outcomes included pain at other time points, functional recovery, quality of life, analgesia use, missed school days, complications, and parental satisfaction.
This was an equivalence trial assessing equivalence in 2 age groups (4-7 and 8-17 years).
A total of 965 patients were randomized: 61% were boys, and the average age was approximately 9 years.
The average pain scores at 3 days were 3.21 points (standard deviation 2.08) in the bandage group and 3.14 points (standard deviation 2.11) in the rigid immobilization group, according to a modified intention-to-treat analysis; 11% of patients in the bandage group crossed over to rigid immobilization.
Pain scores were equivalent in both intention-to-treat and per-protocol analyses at all assessed time points, including at 1 day, 1 week, 3 weeks, and 6 weeks, and were equivalent in the dichotomized age subgroups.
No differences were observed in functional recovery, health-related quality of life at 6 weeks, complications (which were very rare, at <1%, and involved no worsening of deformity) or missed days of school (1.5 days).
Analgesia use was slightly higher in the bandage group on day 1 (83% vs 78%) but did not differ between groups at any other time point.
Parental satisfaction was slightly higher in the rigid-splint group on day 1, did not differ by the end of the 6-week follow-up, and was very high overall in both groups.
This is a well-designed, well-conducted, and well-analyzed study showing true equivalence between the evaluated treatment options for torus fractures in children.
EDITOR’S COMMENTARY: In the large and well-done randomized trial from 23 EDs in the U.K., the authors found equivalence in satisfaction, pain, and clinical outcomes between offering a gauze wrap and immobilization for children with isolated acute torus fractures of the distal radius. Informatively, the authors indicated that parents would not have been happy with no treatment, thus highlighting the value of shared decision-making. Know that no treatment or some gauze is a safe option that allows for a quick discharge, but if parents want a removable splint, that is OK, too.
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