Nonsurgical casting may not meet non-inferiority criteria compared with surgical reduction in pediatric patients with severely displaced distal radial fractures, although the difference in function at 3 months may be small and not persist over time, according to a recent study.

In the multicenter, randomized, controlled noninferiority CRAFFT trial, conducted across 49 UK hospitals, researchers randomly assigned 750 patients aged 4 to 10 years with severely displaced distal radial fractures to undergo nonsurgical casting or surgical reduction. The primary outcome was upper limb function at 3 months, which the researchers measured using the Patient Report Outcomes Measurement Information System (PROMIS) Upper Extremity Score for Children.

At 3 months, the mean function scores were lower in the casting group compared with in the surgical group (44.9 vs 46.6), with a mean difference of –1.64 points favoring the surgical intervention. This crossed the prespecified non-inferiority margin, demonstrating that nonsurgical casting didn't meet the statistical threshold. However, the differences in function between the groups diminished over time, with no statistically significant difference between nonsurgical casting and surgical reduction at 6 and 12 months.

Subgroup analyses showed similar findings across fracture types and age groups. Among patients with completely off-ended fractures, casting met non-inferiority criteria against a wider, clinically relevant margin defined for that subgroup.

Secondary outcomes showed modest early advantages with surgery. Patients in the surgical group had better cosmetic scores and slightly higher quality-of-life measures during early follow-up; however, these differences narrowed by the 12-month follow-up. Pain scores were similar between both patient groups, showing rapid improvement during the first 3 months, with differences below clinically meaningful thresholds.

Complications within 8 weeks occurred more frequently in the surgical group, including wound infections, scarring, and nerve irritation. Refracture was uncommon in both groups over 12 months. In addition, nonsurgical casting was associated with lower costs and a small decrease in quality-adjusted life-years, but remained cost-effective at standard thresholds.

Key limitations include the conservative non-inferiority margin, crossover between treatment groups, and restriction to patients aged 4 to 10 years, which may have limited generalizability to older patients. Variation in care across centers may also influence outcomes.

“[T]he observed difference in favor of surgical reduction was small, below thresholds that families considered meaningful, and did not persist beyond early recovery,” wrote lead study author Daniel C. Perry, PhD, of the University of Liverpool, and colleagues.

The study was funded by the UK National Institute for Health and Care Research. Full disclosures of the study authors can be found in the study.

Source: The Lancet