Three-Dimensional Corrective Osteotomy for Malunited Fractures of the Upper Extremity Using Patient-Matched Instruments A Prospective, Multicenter, Open-Label, Single-Arm Trial
Three-Dimensional Corrective Osteotomy for Malunited Fractures of the Upper Extremity Using Patient-Matched Instruments A Prospective, Multicenter, Open-Label, Single-Arm Trial
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DOI：
10.2106/jbjs.18.00765
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发表时间：
2019-04-17
影响因子：
5.3
通讯作者：
Murase, Tsuyoshi
中科院分区：
文献类型：
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作者：
Oka, Kunihiro;Tanaka, Hiroyuki;Murase, Tsuyoshi
背景资料：医学图像处理促进了三维（3-D）矫正截骨术的模拟，3-D快速原型技术进一步实现了患者匹配手术导向器和植入物（患者匹配器械或PMI）的制造。然而，使用这些技术的3-D矫正截骨术尚未成为标准程序。我们的目的是前瞻性地验证的有效性和安全性的PMI在矫正截骨畸形的上肢。方法：我们招募了16例患者，共17个骨畸形的上肢。桡骨远端畸形愈合8例，肱骨远端畸形愈合5例，前臂骨干畸形愈合3例。所有病例均行三维矫形截骨术。主要终点是残余最大畸形角（MDA），根据2个畸形角计算-1个在前后位，1个在术后侧位X线片。次要终点包括X线片上的畸形角度、术前计划模型和术后结果之间的3-D误差、活动范围、握力、用视觉模拟量表（VAS）测量的疼痛、患者满意度和臂、肩和手残疾（DASH）评分。平均MDA从术前的25.5度显著改善至末次随访时的3.3度（p < 0.001）。所有病例的成角畸形均在5度以内，只有1例桡骨远端畸形愈合，其前后位X线片上的角度较高。术后3-D骨模型上观察到的矫正与计划矫正之间的误差< 1度且< 1 mm。治疗桡骨远端畸形愈合的患者的腕关节伸展和前臂旋前显著改善，治疗前臂骨干畸形愈合的患者的旋前改善。平均VAS评分、握力和DASH评分也显著改善。在16例患者中，15例非常满意或满意的outcomes.Conclusions：矫正截骨术使用PMI实现了准确的纠正和良好的功能恢复上肢。虽然我们的研究仅限于对侧无任何畸形的病例，但使用PMI的3-D矫正截骨术解决了上肢复杂畸形的治疗挑战。
Background: Medical image processing has facilitated simulation of 3-dimensional (3-D) corrective osteotomy, and 3-D rapid prototyping technology has further enabled the manufacturing of patient-matched surgical guides and implants (patient-matched instruments, or PMIs). However, 3-D corrective osteotomy using these technologies has not been the standard procedure. We aimed to prospectively verify the efficacy and safety of PMIs in corrective osteotomy for deformities of the upper extremity.Methods: We enrolled 16 patients with a total of 17 bone deformities in the upper extremity. Eight patients had distal radial malunion; 5, distal humeral malunion; and 3, forearm diaphyseal malunion. All cases underwent 3-D corrective osteotomy with PMIs. The primary end point was the residual maximum deformity angle (MDA), which was calculated from 2 deformity angles-1 on the anteroposterior and 1 on the lateral postoperative radiograph. Secondary end points included the deformity angle on radiographs, 3-D error between the preoperative planning model and the postoperative result, range of motion, grip strength, pain measured with a visual analog scale (VAS), patient satisfaction, and Disabilities of the Arm, Shoulder and Hand (DASH) score.Results: The average MDA significantly improved from 25.5 degrees preoperatively to 3.3 degrees at the final follow-up (p < 0.001). The angular deformity was within 5 degrees in all cases, except for 1 with distal radial malunion who had a higher angle on the anteroposterior radiograph. The error between the correction seen on the postoperative 3-D bone model and the planned correction was < 1 degrees and < 1 mm. Flexion and extension of the wrist and pronation of the forearm of the patients treated for distal radial malunion improved significantly, and pronation improved for those treated for forearm diaphyseal malunion. The average VAS score, grip strength, and DASH score significantly improved as well. Of the 16 patients, 15 were very satisfied or satisfied with the outcomes.Conclusions: Corrective osteotomy using PMIs achieved accurate correction and good functional recovery in the upper extremity. Although our study was limited to cases without any deformity on the contralateral side, 3-D corrective osteotomy using PMIs resolved treatment challenges for complex deformities in upper extremities.