SCORE Foundation, Specialized Center of Orthopedic Research and Education/Xpert Clinics Orthopedie, Amsterdam, The Netherlands.
Cohesie, Occupational Health Service, Voorthuizen, The Netherlands.
Bone Joint J. 2021 Jan;103-B(1):98-104. doi: 10.1302/0301-620X.103B1.BJJ-2020-0788.R1.
For many designs of total knee arthroplasty (TKA) it remains unclear whether cemented or uncemented fixation provides optimal long-term survival. The main limitation in most studies is a retrospective or non-comparative study design. The same is true for comparative trials looking only at the survival rate as extensive sample sizes are needed to detect true differences in fixation and durability. Studies using radiostereometric analysis (RSA) techniques have shown to be highly predictive in detecting late occurring aseptic loosening at an early stage. To investigate the difference in predicted long-term survival between cemented, uncemented, and hybrid fixation of TKA, we performed a randomized controlled trial using RSA.
A total of 105 patients were randomized into three groups (cemented, uncemented, and hybrid fixation of the ACS Mobile Bearing (ACS MB) knee system, implantcast). RSA examinations were performed on the first day after surgery and at scheduled follow-up visits at three months, six months, one year, and two years postoperatively. Patient-reported outcome measures (PROMs) were obtained preoperatively and after two years follow-up. Patients and follow-up investigators were blinded for the result of randomization.
RSA secondary stabilization did not show a significant difference between the three types of fixation. A maximum total point motion of less than 0.2 mm in the second postoperative year was shown in each group, which suggests stabilization of the implant. At 24 months after surgery, PROMs significantly improved compared to baseline in all treatment groups. No significant difference was observed between the three groups.
Secondary stabilization measurements in this study demonstrated no significant difference between the groups. In all groups migration stabilized after initial settling of the implant. For this implant the long-term outcome is not expected to be influenced by the type of fixation to the bone. Cite this article: 2021;103-B(1):98-104.
对于许多全膝关节置换术（TKA）的设计，仍不清楚骨水泥固定或非骨水泥固定哪种能提供最佳的长期存活率。大多数研究的主要局限性是回顾性或非对照研究设计。对于仅关注存活率的对照试验也是如此，因为需要大量样本才能检测到固定和耐久性方面的真实差异。使用放射立体测量分析（RSA）技术的研究表明，在早期阶段检测晚期无菌性松动具有高度预测性。为了研究骨水泥固定、非骨水泥固定和 TKA 的混合固定之间预测的长期存活率差异，我们使用 RSA 进行了一项随机对照试验。
共有 105 名患者随机分为三组（骨水泥固定、非骨水泥固定和 ACS 活动衬垫（ACS MB）膝关节系统的混合固定[implantcast]）。术后第一天以及术后 3 个月、6 个月、1 年和 2 年进行 RSA 检查。术前和术后 2 年获得患者报告的结局测量（PROMs）。患者和随访研究人员对随机分组结果不知情。
RSA 二次稳定在三种固定类型之间没有显示出显著差异。每组在术后第二年的最大总点运动均小于 0.2mm，表明植入物稳定。术后 24 个月，所有治疗组的 PROMs 与基线相比均显著改善。三组之间未观察到显著差异。
本研究的二次稳定测量结果表明各组之间没有显著差异。在所有组中，植入物初始稳定后，迁移稳定。对于该植入物，预计固定方式不会影响其长期结果。
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