Non-surgical casting versus surgical reduction for children with severely displaced distal radial fractures (the CRAFFT Study): a multicentre, randomised, controlled non-inferiority trial and economic evaluation.

Summary

In 750 children randomized across 49 UK hospitals, surgical reduction yielded a small short-term functional advantage at 3 months (adjusted mean difference -1.64 points favoring surgery), but this did not meet a conservative non-inferiority margin for casting and did not persist beyond early recovery. Surgical reduction incurred higher early complications and substantially higher costs; casting was cost-effective with 100% probability at standard UK thresholds and only a modest cosmetic benefit of surgery.

Key Findings

• 750 children randomized (375 casting, 375 surgical reduction) across 49 UK hospitals; median age 7.9 years.
• At 3 months, PROMIS Upper Extremity scores: 44.9 (casting) vs 46.6 (surgery); adjusted mean difference -1.64 (95% CI -2.84 to -0.44).
• Overall non-inferiority of casting not demonstrated against a conservative -2.5 margin; non-inferiority supported in the completely off-ended subgroup using a -5 margin.
• Early complications more frequent after surgery (pressure damage n=2, wound infection n=6, scarring n=5, nerve irritation n=1).
• Refracture over 12 months: 9 (casting) vs 4 (surgery).
• Casting reduced mean cost per patient by £1665 with a small QALY decrement (-0.023), remaining 100% cost-effective at £20,000–30,000/QALY thresholds.

Clinical Implications

For most 4–10-year-olds with severely displaced distal radial fractures, clinicians can consider cast-first management, counseling families that surgical reduction offers only a small, non-durable functional benefit, modest cosmetic improvement, higher early complication risk, and greater cost.

Limitations

• Participants and families were unmasked, introducing potential expectation bias.
• Conservative non-inferiority margin not met in the overall cohort; longer-term outcomes pending extended follow-up.
• Potential selection bias due to lack of equipoise in a substantial proportion of screened patients.

Future Directions

Report 3-year outcomes, refine indications for surgery, incorporate patient-reported cosmesis, and evaluate implementation strategies for cast-first care.