The Joint Replacement Center of Seoul Metropolitan Government, SeoNam Hospital, Seoul, Republic of Korea.
Department of Orthopedic Surgery, Seoul Hospital, Ewha Womans University, Seoul, Republic of Korea.
J Bone Joint Surg Am. 2024 Nov 6;106(21):1978-1985. doi: 10.2106/JBJS.24.00007. Epub 2024 Sep 27.
Many authors and the data of multiple registries have suggested that the use of posterior cruciate-substituting (posterior stabilized [PS]) total knee arthroplasty (TKA) leads to a higher risk of revision compared with the use of posterior cruciate-retaining (CR) TKA. The aim of the present prospective, randomized, long-term study was to compare PS and CR TKA with regard to the clinical, radiographic, and computed tomography (CT) results; the prevalence of osteolysis; revision rate; and survivorship.
This study included a consecutive series of 300 patients (mean age [and standard deviation], 63.6 ± 6 years) who underwent simultaneous, bilateral TKA in the same anesthetic session. Each patient received a NexGen CR-Flex prosthesis on 1 side and a NexGen LPS-Flex prosthesis on the contralateral side. The mean follow-up period was 18 years (range, 17.5 to 19.5 years).
There were no significant differences between the NexGen CR and LPS-Flex TKA groups at the latest follow-up with regard to the mean Knee Society knee score (93 versus 92 points, respectively); the Western Ontario and McMaster Universities Osteoarthritis Index score (19.1 points for both); the University of California Los Angeles activity score (6.1 points for both); range of motion (125° ± 6.1° versus 126° ± 6.5°); radiographic and CT results; and revision rate (6.0% versus 6.3%). No knee had osteolysis. The estimated survival rate at 19.5 years was 94% (95% confidence interval [CI], 91% to 100%) for the NexGen CR-Flex prosthesis and 93.7% (95% CI, 91% to 100%) for the LPS-Flex prosthesis, with revision or aseptic loosening as the end point.
The findings of the present, long-term (minimum follow-up of 17.5 years) clinical study showed that NexGen CR-Flex and NexGen LPS-Flex implants produced excellent clinical and radiographic results. There was no notable clinical advantage of a NexGen CR-Flex implant over a NexGen LPS-Flex implant.
Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.
许多作者和多个登记处的数据表明，与使用后交叉韧带保留（CR）全膝关节置换术（TKA）相比，使用后交叉韧带替代（后稳定型[PS]）TKA 会增加翻修的风险。本前瞻性、随机、长期研究的目的是比较 PS 和 CR TKA 在临床、影像学和计算机断层扫描（CT）结果、骨溶解的发生率、翻修率和生存率方面的差异。
本研究纳入了 300 例连续患者（平均年龄[和标准差]，63.6±6 岁），这些患者在同一次麻醉下同时接受双侧 TKA。每位患者一侧使用 NexGen CR-Flex 假体，另一侧使用 NexGen LPS-Flex 假体。平均随访时间为 18 年（范围 17.5 至 19.5 年）。
在末次随访时，NexGen CR 和 LPS-Flex TKA 组之间在平均膝关节学会膝关节评分（分别为 93 分和 92 分）、西安大略和麦克马斯特大学骨关节炎指数评分（均为 19.1 分）、加利福尼亚大学洛杉矶活动评分（均为 6.1 分）、运动范围（125°±6.1°和 126°±6.5°）、影像学和 CT 结果以及翻修率（6.0%和 6.3%）方面均无显著差异。无膝关节发生骨溶解。在 19.5 年时，NexGen CR-Flex 假体的估计生存率为 94%（95%置信区间[CI]，91%至 100%），LPS-Flex 假体的估计生存率为 93.7%（95%CI，91%至 100%），以翻修或无菌性松动为终点。
本长期（最低随访 17.5 年）临床研究的结果表明，NexGen CR-Flex 和 NexGen LPS-Flex 植入物均产生了优异的临床和影像学结果。与 NexGen LPS-Flex 植入物相比，NexGen CR-Flex 植入物没有明显的临床优势。
治疗性 II 级。请参阅作者说明，以获取完整的证据水平描述。
