The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway.
Faculty of Health Science, VID Specialized University, Oslo, Norway.
JAMA Netw Open. 2024 May 1;7(5):e2412898. doi: 10.1001/jamanetworkopen.2024.12898.
Despite increased use of antibiotic-loaded bone cement (ALBC) in joint arthroplasty over recent decades, current evidence for prophylactic use of ALBC to reduce risk of periprosthetic joint infection (PJI) is insufficient.
To compare the rate of revision attributed to PJI following primary total knee arthroplasty (TKA) using ALBC vs plain bone cement.
DESIGN, SETTING, AND PARTICIPANTS: This international cohort study used data from 14 national or regional joint arthroplasty registries in Australia, Denmark, Finland, Germany, Italy, New Zealand, Norway, Romania, Sweden, Switzerland, the Netherlands, the UK, and the US. The study included primary TKAs for osteoarthritis registered from January 1, 2010, to December 31, 2020, and followed-up until December 31, 2021. Data analysis was performed from April to September 2023.
Primary TKA with ALBC vs plain bone cement.
The primary outcome was risk of 1-year revision for PJI. Using a distributed data network analysis method, data were harmonized, and a cumulative revision rate was calculated (1 - Kaplan-Meier), and Cox regression analyses were performed within the 10 registries using both cement types. A meta-analysis was then performed to combine all aggregated data and evaluate the risk of 1-year revision for PJI and all causes.
Among 2 168 924 TKAs included, 93% were performed with ALBC. Most TKAs were performed in female patients (59.5%) and patients aged 65 to 74 years (39.9%), fully cemented (92.2%), and in the 2015 to 2020 period (62.5%). All participating registries reported a cumulative 1-year revision rate for PJI of less than 1% following primary TKA with ALBC (range, 0.21%-0.80%) and with plain bone cement (range, 0.23%-0.70%). The meta-analyses based on adjusted Cox regression for 1 917 190 TKAs showed no statistically significant difference at 1 year in risk of revision for PJI (hazard rate ratio, 1.16; 95% CI, 0.89-1.52) or for all causes (hazard rate ratio, 1.12; 95% CI, 0.89-1.40) among TKAs performed with ALBC vs plain bone cement.
In this study, the risk of revision for PJI was similar between ALBC and plain bone cement following primary TKA. Any additional costs of ALBC and its relative value in reducing revision risk should be considered in the context of the overall health care delivery system.
尽管近几十年来关节置换术中抗生素骨水泥(ALBC)的使用有所增加,但目前关于预防性使用 ALBC 以降低假体周围关节感染(PJI)风险的证据仍然不足。
比较初次全膝关节置换术(TKA)中使用 ALBC 与普通骨水泥时 PJI 导致的翻修率。
设计、地点和参与者:这项国际队列研究使用了来自澳大利亚、丹麦、芬兰、德国、意大利、新西兰、挪威、罗马尼亚、瑞典、瑞士、荷兰、英国和美国的 14 个国家或地区关节置换登记处的数据。该研究纳入了 2010 年 1 月 1 日至 2020 年 12 月 31 日登记的原发性 TKA,并随访至 2021 年 12 月 31 日。数据分析于 2023 年 4 月至 9 月进行。
初次 TKA 中使用 ALBC 与普通骨水泥。
主要结局为 PJI 发生 1 年翻修的风险。使用分布式数据网络分析方法,对数据进行了调和,并计算了累积翻修率(1- Kaplan-Meier),并在使用两种水泥类型的 10 个登记处内进行了 Cox 回归分析。然后进行了荟萃分析,合并所有汇总数据,并评估了 1 年 PJI 和所有原因的翻修风险。
在纳入的 2168924 例 TKA 中,93% 采用了 ALBC。大多数 TKA 是在女性患者(59.5%)和 65 至 74 岁患者(39.9%)中进行的,采用了完全骨水泥固定(92.2%),并且在 2015 年至 2020 年期间进行(62.5%)。所有参与的登记处报告初次 TKA 后使用 ALBC 的 PJI 1 年累积翻修率均低于 1%(范围为 0.21%-0.80%)和普通骨水泥(范围为 0.23%-0.70%)。基于对 1917190 例 TKA 的调整后的 Cox 回归的荟萃分析显示,在 1 年时,使用 ALBC 与普通骨水泥相比,PJI(危险比,1.16;95%CI,0.89-1.52)或所有原因(危险比,1.12;95%CI,0.89-1.40)的翻修风险无统计学显著差异。
在这项研究中,初次 TKA 后使用 ALBC 和普通骨水泥时 PJI 的翻修风险相似。在考虑 ALBC 的相对价值及其在降低翻修风险方面的作用时,应考虑其对整体医疗保健系统的影响。