Department of Orthopaedic Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Health and Counseling Center, Osaka University, Toyonaka, Japan.
J Bone Joint Surg Am. 2019 Apr 17;101(8):710-721. doi: 10.2106/JBJS.18.00765.
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.
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.
The average MDA significantly improved from 25.5° preoperatively to 3.3° at the final follow-up (p < 0.001). The angular deformity was within 5° 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° 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.
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.
Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
医学图像处理促进了三维（3-D）矫正性截骨术的模拟，3-D 快速成型技术进一步实现了与患者匹配的手术导板和植入物（与患者匹配的器械，或 PMIs）的制造。然而，这些技术的 3-D 矫正性截骨术尚未成为标准程序。我们旨在前瞻性验证 PMIs 在矫正上肢畸形中的疗效和安全性。
我们纳入了 16 名上肢共 17 处骨骼畸形的患者。8 例为桡骨远端愈合不良；5 例为肱骨远端愈合不良；3 例为前臂骨干愈合不良。所有病例均采用 PMIs 行 3-D 矫正性截骨术。主要终点为残余最大畸形角（MDA），该角由术后正位和侧位 2 个畸形角计算得出。次要终点包括影像学上的畸形角度、术前规划模型与术后结果之间的 3-D 误差、关节活动度、握力、视觉模拟评分（VAS）测量的疼痛、患者满意度以及上肢残疾评分（DASH）。
平均 MDA 从术前的 25.5°显著改善至末次随访时的 3.3°（p < 0.001）。除 1 例桡骨远端愈合不良患者的正位片上存在较大角度外，所有病例的角度畸形均在 5°以内。术后 3-D 骨模型上所见的矫正与计划矫正之间的误差小于 1°和 1mm。桡骨远端愈合不良患者的腕关节屈伸和前臂旋前活动度显著改善，前臂骨干愈合不良患者的旋前活动度改善。平均 VAS 评分、握力和 DASH 评分也显著改善。16 例患者中，15 例对治疗结果非常满意或满意。
使用 PMIs 进行矫正性截骨术可在上肢实现精确矫正和良好的功能恢复。尽管我们的研究仅限于对侧无畸形的病例，但使用 PMIs 的 3-D 矫正性截骨术解决了上肢复杂畸形的治疗挑战。
治疗性 IV 级。请参阅作者说明以获取完整的证据等级描述。
