个性化定制股骨截骨导板在单髁置换中精确性的实验研究

Accuracy of individualized custom femoral cutting guides in unicompartmental knee arthroplasty of femoral specimens

目的 探讨个性化定制股骨截骨导板在股骨标本单髁置换（UKA）术中应用的可行性和准确性,为临床应用提供实验性依据.方法 2016年1月—2017年2月选取复旦大学医学院解剖教研室成人股骨标本40根,男性22根、女性18根,年龄35~78岁,身高152~178 cm.采用数字表法随机分为导板组和对照组,每组20例.导板组采用个性化定制股骨截骨导板辅助UKA手术,术前采用薄层CT扫描对股骨进行医学图像数据采集,然后利用3D反求技术进行导航模板的设计,再采用3D打印技术制造个性化定制股骨截骨导板,并进行UKA术.对照组在UKA术中采用传统定位截骨.手术均由同一组医疗小组完成.评估两组标本的股骨侧手术截骨时间,并采用影像学评价下股骨假体力线和假体位置.结果 导板组术中导板与股骨髁骨性解剖结构贴合紧密,无明显移动.导板组与对照组手术截骨时间分别为（3.31±0.56）min和（4.45±0.74）min（t=-5.500,P〈0.01）,股骨假体内/外翻角度分别为1.31° ±0.86°和2.84° ±1.58°（t=-3.789,P〈0.01）,股骨假体后倾角度分别为8.84° ±0.60°和6.25° ±1.96°（t=5.661,P〈0.01）,差异均有统计学意义.导板组的股骨假体内/外翻角及后倾角更接近0°和10°,并且离散度小.结论 个性化定制股骨截骨导板用于UKA术能提高股骨假体冠状位和矢状位力线的精确性,缩短手术时间.

Objective To explore the feasibility and accuracy of the Individualized Custom Femoral Cutting Guides in unicompartmental knee arthroplasty （ UKA） of femoral specimens, and provide an experimental basis for clinical application. Methods From January 2016 to February 2017, 40 adult femoral specimens were selected from the Department of anatomy, affiliated medical university of Fudan University. There were 22 males and 18 females. The age was 35 - 78 years and the height was 152 -178 cm. The digital table method was randomly divided into the trial group（individualized custom femoral cutting guides group, 20 femurs） and the control group（20 femurs）. The trial group used individualized custom femoral cutting guides assisted UKA surgery, CT was performed preoperatively for data collection, and then design a cutting guide with 3D reverse technology, then 3D printing technology was used to produce individualized custom femoral cutting guide. At last, the surgery navigation templates were applied in the personalized UKA. In the control group, conventional fixation osteotomy was used in UKA. The operation was performed in the same group of medical groups. The two groups were compared in terms of osteotomy time and alignment of the lower limb. Results In the trial group, the navigation templates all contacted closely the bony structures of femoral condyle with no displacement. The osteotomy time were （3. 31 ± 0. 56） min the trial group and （4. 45 ± 0. 74） min in the control group, respectively （t = - 5. 500, P 〈0. 01）. The postoperative femoral component valgus/ varus angle （FCVA） were 1. 31° ± 0. 86° in the trial group and 2. 84° ± 1. 58° in the control group, respectively （t = - 3. 789, P 〈 0. 01） . Correspondingly, the femoral component posterior slope angle （FCPSA） were 8. 84° ± 0. 60° and 6. 25° ± 1. 96°, respectively （t = 5. 661, P 〈 0. 01） . There was significant difference between the two groups, the postoperative tibial component valgus/ varus angle and tibial component posterior slope angle in the trial group were closer to 0° and 10° , respectively, which indicated the position of femoral prosthesis was more precise. Conclusions The individualized custom femoral cutting guides does improve the accuracy of femoral prosthesis position in UKA and saving time.