PDF(Pubmed)
Abstract：
UNASSIGNED: To date, there is currently no evidence-based medical support for the efficacy of topology-optimized splints in treating distal radius fractures.
UNASSIGNED: To assess the clinical efficacy and complication rates of topology-optimized splints in the treatment of distal radius fractures after closed manual reduction.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: Chinese Clinical Trial Registry: ChiCTR2000036480.
UNASSIGNED: To assess the clinical efficacy and complication rates of topology-optimized splints in the treatment of distal radius fractures after closed manual reduction.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: Chinese Clinical Trial Registry: ChiCTR2000036480.
摘要：
■到目前为止，目前对于拓扑优化夹板治疗桡骨远端骨折的疗效尚无循证医学支持.
■评估闭合手动复位后拓扑优化的夹板治疗桡骨远端骨折的临床疗效和并发症发生率。
■这12周，多中心，开放标签，从2021年12月3日至2023年3月10日,在110例桡骨远端骨折参与者中,进行了分析者盲法随机临床试验(包括6周干预,然后是6周观察阶段).在2023年6月3日至30日期间，在意向治疗的基础上进行了统计分析。
■参与者被随机分配到2组：干预组接受拓扑优化的夹板固定，对照组在闭合手动复位6周后接受石膏固定。在这段时间之后,固定被移除，手腕康复活动开始。
主要结果是6周时的Gartland-Werley(G-W)腕部评分（评分越高表示腕部功能障碍越严重）。次要结果包括放射学参数，视觉模拟量表评分，肿胀度等级,并发症发生率,和3个维度的G-W腕部评分。
■总共110名患者(平均[SD]年龄，64.1[12.7]年；89名妇女[81%]）参加临床试验，对101例患者(92%)进行了完整的结局测量.6周时G-W得分中位数为15(IQR，13-18）用于夹板组和17（IQR，13-18)对于演员组(平均差，-2.0[95%CI，-3.4至-0.6]；P=0.03)，表明夹板组具有统计学上的显着优势。12周时,两组之间的G-W评分无临床显著性差异.并发症发生率,包括肩肘疼痛和功能障碍以及皮肤刺激，在夹板组中较少见(肩肘疼痛和功能障碍：风险比，0.28[95%CI，0.08-0.93]；P=0.03；皮肤刺激：风险比，0.30[95%CI，0.10-0.89]；P=.02）。
这项随机临床试验的结果表明，与接受铸造的患者相比，接受拓扑优化夹板治疗的桡骨远端骨折患者在6周时具有更好的腕关节功能结果和更少的并发症。在第12周没有区别。因此,具有改进性能的拓扑优化夹板有可能成为治疗桡骨远端骨折的一种可取方法.
■中国临床试验注册中心：ChiCTR2000036480。
■评估闭合手动复位后拓扑优化的夹板治疗桡骨远端骨折的临床疗效和并发症发生率。
■这12周，多中心，开放标签，从2021年12月3日至2023年3月10日,在110例桡骨远端骨折参与者中,进行了分析者盲法随机临床试验(包括6周干预,然后是6周观察阶段).在2023年6月3日至30日期间，在意向治疗的基础上进行了统计分析。
■参与者被随机分配到2组：干预组接受拓扑优化的夹板固定，对照组在闭合手动复位6周后接受石膏固定。在这段时间之后,固定被移除，手腕康复活动开始。
主要结果是6周时的Gartland-Werley(G-W)腕部评分（评分越高表示腕部功能障碍越严重）。次要结果包括放射学参数，视觉模拟量表评分，肿胀度等级,并发症发生率,和3个维度的G-W腕部评分。
■总共110名患者(平均[SD]年龄，64.1[12.7]年；89名妇女[81%]）参加临床试验，对101例患者(92%)进行了完整的结局测量.6周时G-W得分中位数为15(IQR，13-18）用于夹板组和17（IQR，13-18)对于演员组(平均差，-2.0[95%CI，-3.4至-0.6]；P=0.03)，表明夹板组具有统计学上的显着优势。12周时,两组之间的G-W评分无临床显著性差异.并发症发生率,包括肩肘疼痛和功能障碍以及皮肤刺激，在夹板组中较少见(肩肘疼痛和功能障碍：风险比，0.28[95%CI，0.08-0.93]；P=0.03；皮肤刺激：风险比，0.30[95%CI，0.10-0.89]；P=.02）。
这项随机临床试验的结果表明，与接受铸造的患者相比，接受拓扑优化夹板治疗的桡骨远端骨折患者在6周时具有更好的腕关节功能结果和更少的并发症。在第12周没有区别。因此,具有改进性能的拓扑优化夹板有可能成为治疗桡骨远端骨折的一种可取方法.
■中国临床试验注册中心：ChiCTR2000036480。
