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
21.2
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.
Open reference URL