DRAFFT2
Trial question
Is surgical fixation with K-wires superior to casting in patients with dorsally-displaced distal radius fracture?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
83.0% female
17.0% male
N = 500
500 patients (417 female, 83 male).
Inclusion criteria: adult patients with a dorsally-displaced distal radius fracture that needed manipulation.
Key exclusion criteria: injury > 2 weeks old; fracture extending > 3 cm from radiocarpal joint; open fracture with Gustilo and Anderson grading > 1; inability to reduce the joint surface of fracture by closed manipulation.
Interventions
N=245 K-wire fixation (manipulation and surgical fixation with K-wires plus cast).
N=255 cast (manipulation and moulded cast only).
Primary outcome
Patient Rated Wrist Evaluation score at 12 months
20.7 points
21.2 points
21.2 points
15.9 points
10.6 points
5.3 points
0.0 points
K-wire
fixation
Cast
No significant
difference ↔
No significant difference in Patient Rated Wrist Evaluation score at 12 months (20.7 points vs. 21.2 points; MD -0.34, 95% CI -4.33 to 3.66).
Secondary outcomes
No significant difference in Patient Rated Wrist Evaluation at 6 months (27.6 vs. 28.4; MD -0.32, 95% CI -4.26 to 3.62).
No significant difference in the mean score of EuroQol-5D at 12 months (0.78 points vs. 0.81 points; AD -0.03 points, 95% CI -0.07 to 0.02).
No significant difference in the mean score of EuroQol VAS at 12 months (80.42 points vs. 81.11 points; AD -0.51 points, 95% CI -4.3 to 3.29).
Safety outcomes
No significant differences in blood clots, complex regional pain syndrome.
Significant difference in surgery for loss of fracture reduction in the first 6 weeks (0.4% vs. 13%).
Conclusion
In adult patients with a dorsally-displaced distal radius fracture that needed manipulation, K-wire fixation was not superior to cast with respect to Patient Rated Wrist Evaluation score at 12 months.
Reference
Matthew L Costa, Juul Achten, Alexander Ooms et al. Surgical fixation with K-wires versus casting in adults with fracture of distal radius: DRAFFT2 multicentre randomised clinical trial. BMJ. 2022 Jan 19;376:e068041.
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