个性化与常规导向器单髁置换前瞻性随机比较△（开放获取）

(Open Access) A prospective random comparison of personalized guide versus conventional counterpart for unicompartmental knee arthroplasty

摘要:

[目的] 比较初学者使用个性化定制导板（patient-specific instrumentation, PSI） 与经验丰富医生使用常规截骨导板行膝关节单髁置换术（unicompartmental knee arthroplasty, UKA） 的临床疗效。[方法] 2022 年1 月—2022 年11 月，共计44 例拟行单侧UKA 的患者纳入本研究，随机分为两组。其中，22 例由UKA 初学者采用个性化定制截骨导板（PSI 组），22 例由UKA经验丰富医生采用厂家提供的常规截骨导板（Oxford Microplasty, OMP 组）。比较两组围手术期、随访及影像结果。[结果] PSI组的手术时间[(65.2±6.1 ) min vs (58.1±3.9) min, P＜0.001] 显著长于OMP 组，两组切口总长度、术中失血量、垫片厚度、下地行走时间、切口愈合等级、住院时间的差异无统计学意义（P＞0.05）。随访时间平均（18.0±3.2） 个月，两组患者完全负重活动时间的差异无统计学意义（P＞0.05）。随时间推移，两组患者VAS 评分、HSS 评分、KSS 评分、FJS 评分和ROM 均显著改善（P＜0.05）；相应时间点，两组间上述指标的差异均无统计学意义（P＞0.05）。影像方面，与术后即刻相比，末次随访时，两组患者股骨组件内外翻角（femoral component varus/valgus angle, FVVA）、股骨组件屈伸角（femoral component flexion/extension angle,FFEA）、胫骨组件内外翻角（tibial component varus/valgus angle, TVVA）、胫骨组件后倾角（tibial component posterior slope angle,TPSA） 及股胫机械轴夹角（hip-knee-ankle mechanical angle, HKAA） 均无显著变化（P＞0.05）。相应时间点，两组间上述影像指标的差异均无统计学意义（P＞0.05）。[结论] 初学者使用PSI 相较于经验丰富医生使用OMP 行UKA，前者手术时间相对长，但两者在围手术期损伤控制、功能评分及影像指标方面结果相似。PSI 可作为UKA 初学者的备选工具，缩短学习曲线。

Abstract:

[Objective] To compare the clinical outcomes of unicompartmental knee arthroplasty (UKA) by the beginners with the pa-tient-specific instrumentation (PSI) guide versus the experienced physicians with conventional guide. [Methods] From January 2022 to No-vember 2022, a total of 44 patients who were undergoing unilateral UKA were included in this study and randomly divided into two groups.Of them, 22 patients had UKA performed by the beginners with the personalized osteotomy guides (PSI group), while other 22 patients weretreated by experienced physicians with commercially provided conventional osteotomy guides (Oxford Microplasty) (OMP group). The docu-ments regarding perioperative period, follow-up and images were compared between the two groups. [Results] Although the PIS group con-sumed significantly longer operative time than the OMP group [(65.2±6.1) min vs (58.1±3.9) min, P＜0.001], there were no significant differ-ences in total incision length, intraoperative blood loss, insert thickness, walking time, incision healing grade and hospital stay between thetwo groups (P＞0.05). The mean follow-up time was of (18.0±3.2) months, and there was no significant difference in the total weight-bearingactivity time between the two groups (P＞0.05). The VAS score, HSS score, KSS score, FJS score and ROM were significantly improved inboth groups over time (P＜0.05). At corresponding time points, there was no statistical significance in the above indexes between the twogroups (P＞0.05). Radiographically, the femoral component varus/valgus angle (FVVA), femoral component flexion/extension angle (FVVA),femoral component flexion/extension angle (FFEA), tibial component varus/valgus angle (TVVA), tibial component posterior slope angle (TP-SA) and hip knee ankle angle (HKAA) remained unchanged significantly in both groups at the latest follow-up compared with those immedi-ately after operation (P＞0.05), additionally, which were not significantly different between the two groups at any time points accordingly (P＞0.05). [Conclusion] Compared with experienced doctors using OMP for UKA, the beginners using PSI spend a relatively longer operationtime, but the consequences of the two groups are comparable in perioperative damage control, functional scores and imaging indicators.Therefore, PSI might be used as an alternative tool for UKA beginners to shorten the learning curve.