Background: 

The efficacy of commercially available antibiotic-loaded bone cement (ABC) in preventing infection in total knee arthroplasty (TKA) is unclear. We sought to determine the effectiveness of commercially available ABC in reducing the risk of infection following TKA, both overall and among 3 subgroups of patients with a higher risk of infection (diabetes, body mass index ≥35 kg/m², and American Society of Anesthesiologists classification ≥3), and to evaluate the association between the use of ABC and the risks of aseptic revision and revision for aseptic loosening.

Methods: 

The Kaiser Permanente Total Joint Replacement Registry was utilized to evaluate 87,018 primary cemented TKAs performed from 2008 to 2016. The primary outcome was time to infection (90-day deep infection or septic revision). Reduced infection risk with ABC relative to regular cement was tested with use of propensity-score-weighted Cox proportional-hazards models with superiority and noninferiority testing. All analyses were replicated for each of the 3 high-risk subgroups. For the secondary revision outcomes, propensity-score-weighted Cox proportional-hazards models were utilized.

Results: 

Regular cement was found to be noninferior to ABC with respect to risk infection (hazard ratio [HR], 1.14; 95% confidence interval [CI], 0.93 to 1.40) and cost across all TKA patients. However, a lower risk of infection was observed with ABC among TKA patients with diabetes (HR, 0.72; 95% CI, 0.52 to 0.99). There was no evidence of a difference in risk of revision for ABC compared with regular cement.

Conclusions: 

We found that the additional cost associated with the use of commercially prepared ABC in primary TKA was not justified in all patients; however, the risk of reduction was lower among patients with diabetes who received ABC. Further study is warranted to identify the efficacy of ABC among other high-risk populations.

Level of Evidence: 

Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

中文翻译：

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胶结的初次全膝关节置换术后，商业制备的载有抗生素的骨水泥及其感染风险

背景： 

目前尚不清楚市售的负载抗生素的骨水泥（ABC）在预防全膝关节置换术（TKA）感染中的功效。我们力求确定总体上以及3个感染风险较高的亚组患者（糖尿病，体重指数≥35kg / m ²和美国学会）在降低TKA后TKA感染风险的有效性。麻醉师分类≥3），并评估ABC的使用与无菌翻修风险和无菌松动翻修风险之间的关系。

方法： 

Kaiser永久性全关节置换登记系统用于评估从2008年至2016年进行的87,018例原发性骨水泥TKA。主要结局是感染时间（90天深层感染或脓毒症修复）。使用倾向评分加权的Cox比例风险模型以及优势和非劣效性测试，测试了ABC相对于常规水泥降低的感染风险。对3个高风险亚组中的每个亚组重复所有分析。对于二级修订结果，使用了得分得分加权的Cox比例风险模型。

结果： 

在所有TKA患者中，常规水泥在风险感染方面均不逊于ABC（风险比[HR]为1.14； 95％置信区间[CI]为0.93至1.40）。然而，在患有糖尿病的TKA患者中，ABC的感染风险较低（HR，0.72； 95％CI，0.52至0.99）。没有证据表明与常规水泥相比，ABC翻修风险有所不同。

结论： 

我们发现，并非所有患者都认为在原发性TKA中使用商业制备的ABC相关的额外费用；但是，接受ABC治疗的糖尿病患者降低风险的风险较低。有必要进行进一步的研究来确定ABC在其他高危人群中的疗效。

证据级别： 

治疗级别III。有关证据水平的完整说明，请参见《作者说明》。