%0 Randomized Controlled Trial
%T Topology-Optimized Splints vs Casts for Distal Radius Fractures: A Randomized Clinical Trial.
%A Ma H
%A Ruan B
%A Li J
%A Zhang J
%A Wu C
%A Tian H
%A Zhao Y
%A Feng D
%A Yan W
%A Xi X
%J JAMA Netw Open
%V 7
%N 2
%D 2024 Feb 5
%M 38306099
%F 13.353
%R 10.1001/jamanetworkopen.2023.54359
%X <B>UNASSIGNED: </B>To date, there is currently no evidence-based medical support for the efficacy of topology-optimized splints in treating distal radius fractures.<BR><B>UNASSIGNED: </B>To assess the clinical efficacy and complication rates of topology-optimized splints in the treatment of distal radius fractures after closed manual reduction.<BR><B>UNASSIGNED: </B>This 12-week, multicenter, open-label, analyst-blinded randomized clinical trial (comprising a 6-week intervention followed by a 6-week observational phase) was carried out from December 3, 2021, to March 10, 2023, among 110 participants with distal radius fractures. Statistical analysis was performed on an intention-to-treat basis between June 3 and 30, 2023.<BR><B>UNASSIGNED: </B>Participants were randomly assigned to 2 groups: the intervention group received topology-optimized splint immobilization and the control group received cast immobilization after closed manual reduction for 6weeks. After this period, immobilization was removed, and wrist rehabilitation activities commenced.<BR><B>UNASSIGNED: </B>The primary outcome was the Gartland-Werley (G-W) wrist score at 6 weeks (where higher scores indicate more severe wrist dysfunction). Secondary outcomes encompassed radiographic parameters, visual analog scale scores, swelling degree grade, complication rates, and 3 dimensions of G-W wrist scores.<BR><B>UNASSIGNED: </B>A total of 110 patients (mean [SD] age, 64.1 [12.7] years; 89 women [81%]) enrolled in the clinical trial, and complete outcome measurements were obtained for 101 patients (92%). Median G-W scores at 6 weeks were 15 (IQR, 13-18) for the splint group and 17 (IQR, 13-18) for the cast group (mean difference, -2.0 [95% CI, -3.4 to -0.6]; P = .03), indicating a statistically significant advantage for the splint group. At 12 weeks, no clinically significant differences in G-W scores between the 2 groups were observed. Complication rates, including shoulder-elbow pain and dysfunction and skin irritation, were less common in the splint group (shoulder-elbow pain and dysfunction: risk ratio, 0.28 [95% CI, 0.08-0.93]; P = .03; skin irritation: risk ratio, 0.30 [95% CI, 0.10-0.89]; P = .02).<BR><B>UNASSIGNED: </B>Findings of this randomized clinical trial suggest that patients with distal radius fractures that were managed with topology-optimized splints had better wrist functional outcomes and fewer complications at 6 weeks compared with those who received casting, with no difference at week 12. Therefore, topology-optimized splints with improved performance have the potential to be an advisable approach in the management of distal radius fractures.<BR><B>UNASSIGNED: </B>Chinese Clinical Trial Registry: ChiCTR2000036480.