Ensayo clínico aleatorizado sobre la utilidad de la impresión 3 D en las fracturas intraarticulares de radio distal

P.Á. Sebastián Giraldo , M. Elvira Soler , A. Fernández Kang , F. Martínez Martínez , A. García López
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Abstract

Objectives

We evaluated the utility of 3 D printing technology for preoperative planning in the treatment of intra-articular fractures of the distal radius in relation to the improvement of surgical technique, radiological and clinical results.

Material and methods

A total of 30 patients with 2 B and C fractures of the AO classification were operated on by a single surgeon with a volar plate, randomly divided into two groups, 15 of them with conventional planning (Rx and CT) and 15 adding a 3 D model of the fracture and the previous simulation of the intervention. Simulation time, surgical time in minutes, radioscopy time in minutes, loss of material expressed in lost screws were recorded. Clinical evaluation based PRWE questionnaire and full radiographic analysis was done for all patients with a mean follow-up of 6 months by an independent, blinded observed.

Results

No statistically significant differences were observed in the PRWE questionnaire (p = 0.22), nor were we observed differences in the radiological values, except in relation to the articular step (p = 0.028), which represents statistical significance, but in both groups the median was of 0.0 (0.0–0.0). We also did not see statistically significant differences in surgical times (p = 0.745), radioscopy (p = 0.819) or in the loss of synthesis material (p = 0.779).

Conclusions

3 D printing has not improved the parameters studied in relation to routinely operated patients.
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关于3D打印在远距骨内骨折中的效用的随机临床试验
目的评价3d打印技术在桡骨远端关节内骨折治疗的术前规划中的应用,以提高手术技术、影像学和临床效果。材料与方法30例AO分型2例B、C型骨折患者,由同一位外科医生用掌侧钢板进行手术,随机分为两组,15例采用常规方案(Rx + CT), 15例采用骨折三维模型及前期模拟干预。记录模拟时间、手术时间(分钟)、放射线检查时间(分钟)、以螺钉丢失表示的材料损失。通过独立、盲法观察,对所有患者进行了平均6个月的随访,并基于PRWE问卷和完整的放射学分析进行了临床评估。结果PRWE问卷调查结果无统计学差异(p = 0.22),放射学值除与关节步长有关(p = 0.028)外,无统计学差异(p = 0.028),但两组中位数均为0.0(0.0 - 0.0)。在手术时间(p = 0.745)、放射检查(p = 0.819)或合成材料损失(p = 0.779)方面,我们也没有发现统计学上的显著差异。结论3d打印并没有改善常规手术患者的各项参数。
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来源期刊
CiteScore
1.10
自引率
0.00%
发文量
156
审稿时长
51 weeks
期刊介绍: Es una magnífica revista para acceder a los mejores artículos de investigación en la especialidad y los casos clínicos de mayor interés. Además, es la Publicación Oficial de la Sociedad, y está incluida en prestigiosos índices de referencia en medicina.
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