Sint Maartenskliniek Research, Sint Maartenskliniek, P.O. Box 9011, 6500 GM, Nijmegen, The Netherlands.
Department of Orthopedic Surgery, Sint Maartenskliniek, Nijmegen, The Netherlands.
Knee Surg Sports Traumatol Arthrosc. 2018 Jun;26(6):1792-1799. doi: 10.1007/s00167-017-4792-3. Epub 2017 Nov 28.
The primary aim of the study was to examine stability and alignment after total knee arthroplasty (TKA) using patient-specific instrumentation (PSI) and conventional instrumentation (CI). The hypothesis was that stability and alignment would be better using PSI than CI, 12 months postoperatively. The secondary aim included the evaluation of clinical outcomes after TKA.
In this prospective randomized controlled trial, 42 patients with knee osteoarthritis received a Genesis II PS prosthesis with either PSI or CI. Patients visited the hospital preoperatively and postoperatively after 6 weeks and 3 and 12 months. To evaluate stability, varus-valgus laxity was determined in extension and flexion using stress radiographs 12 months postoperatively. Three months postoperatively, a long-leg radiograph and CT scan were obtained to measure hip-knee-ankle (HKA) alignment and component rotation. Furthermore, frontal and sagittal alignment of the components, the Knee Society Score, VAS Pain, VAS Satisfaction, Knee injury and Osteoarthritis Outcome score, Patella score (Kujala), University of California Los Angeles activity score, anterior-posterior laxity, (serious) adverse device-related events, and intraoperative complications were reported. The clinical outcomes were compared using independent t tests or non-parametric alternatives, and repeated measurements ANOVA with a significance level of p < 0.05.
No significant differences were found between the two groups regarding stability, HKA angle, and rotational alignment. In four patients, the PSI did not fit correctly on the tibia and/or femur requiring intraoperative modifications. Both groups improved significantly over time on all clinical outcomes, with no significant differences between the groups 12 months postoperatively. The PSI group showed less tibial slope than the patients in the CI group [PSI 2.6° versus CI 4.8° (p = 0.02)]. Finally, the PSI group more frequently received a thinner insert size than the CI group (p = 0.03).
Patients operated with PSI did not differ from CI in terms of stability and alignment. However, in the PSI group ligament releases were more often required intraoperatively. Furthermore, the two methods did not show different clinical results. It seems that the preoperative planning for the PSI facilitates more conservative bone cuts than CI, but whether this is clinically relevant should be investigated. Since PSI is more expensive and time consuming than CI, and does not outperform CI with regard to clinical results, we recommend to use CI.
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本研究的主要目的是检查使用患者特异性器械（PSI）和常规器械（CI）进行全膝关节置换术（TKA）后的稳定性和对齐情况。假设术后 12 个月，PSI 比 CI 的稳定性和对齐效果更好。次要目标包括评估 TKA 后的临床结果。
在这项前瞻性随机对照试验中，42 例膝关节骨关节炎患者接受了 Genesis II PS 假体，使用 PSI 或 CI。患者在术前、术后 6 周、3 个月和 12 个月时就诊。为了评估稳定性，术后 12 个月时通过应力射线照相测量在伸展和屈曲时的内翻-外翻松弛度。术后 3 个月，获取长腿 X 线片和 CT 扫描以测量髋膝踝（HKA）对齐和组件旋转。此外，还报告了组件的额状面和矢状面对齐、膝关节学会评分、视觉模拟评分疼痛、视觉模拟评分满意度、膝关节损伤和骨关节炎结果评分、髌骨评分（Kujala）、加利福尼亚大学洛杉矶活动评分、前后松弛度、（严重）不良器械相关事件和术中并发症。使用独立 t 检验或非参数替代方法比较临床结果，并使用具有显著性水平 p<0.05 的重复测量方差分析。
两组在稳定性、HKA 角度和旋转对齐方面没有发现显著差异。在 4 例患者中，PSI 在胫骨和/或股骨上的适配不正确，需要术中修改。两组在所有临床结果上均随时间显著改善，术后 12 个月时两组之间无显著差异。PSI 组的胫骨倾斜度小于 CI 组[PSI 2.6°与 CI 4.8°（p=0.02）]。最后，PSI 组比 CI 组更频繁地使用较薄的插入物尺寸（p=0.03）。
PSI 组患者在稳定性和对齐方面与 CI 组没有差异。然而，在 PSI 组中，术中更常需要进行韧带松解。此外，两种方法的临床结果没有差异。似乎 PSI 的术前规划比 CI 更有利于更保守的骨切割，但这是否具有临床意义仍需进一步研究。由于 PSI 比 CI 更昂贵且耗时，并且在临床结果方面并不优于 CI，因此我们建议使用 CI。
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