George Jaiben, Kwiecien Grzegorz, Klika Alison K, Ramanathan Deepak, Bauer Thomas W, Barsoum Wael K, Higuera Carlos A
Department of Orthopaedic Surgery, Cleveland Clinic, Mail Code: A-41, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Department of Pathology, Cleveland Clinic, Cleveland, OH, USA.
Clin Orthop Relat Res. 2016 Jul;474(7):1619-26. doi: 10.1007/s11999-015-4673-3.
Frozen section histology is widely used to aid in the diagnosis of periprosthetic joint infection at the second stage of revision arthroplasty, although there are limited data regarding its utility. Moreover, there is no definitive method to assess control of infection at the time of reimplantation. Because failure of a two-stage revision can have serious consequences, it is important to identify the cases that might fail and defer reimplantation if necessary. Thus, a reliable test providing information about the control of infection and risk of subsequent failure is necessary.
QUESTIONS/PURPOSES: (1) At second-stage reimplantation surgery, what is the diagnostic accuracy of frozen sections as compared with the Musculoskeletal Infection Society (MSIS) as the gold standard? (2) What are the diagnostic accuracy parameters for the MSIS criteria and frozen sections in predicting failure of reimplantation? (3) Do positive MSIS criteria or frozen section at the time of reimplantation increase the risk of subsequent failure?
A total of 97 patients undergoing the second stage of revision total hip arthroplasty or total knee arthroplasty in 2013 for a diagnosis of periprosthetic joint infection (PJI) were considered eligible for the study. Of these, 11 had incomplete MSIS criteria and seven lacked 1-year followup, leaving 79 patients (38 knees and 41 hips) available for analysis. At the time of reimplantation, frozen section results were compared with modified MSIS criteria as the gold standard in detecting infection. Subsequently, success or failure of reimplantation was defined by (1) control of infection, as characterized by a healed wound without fistula, drainage, or pain; (2) no subsequent surgical intervention for infection after reimplantation surgery; and (3) no occurrence of PJI-related mortality; and diagnostic parameters in predicting treatment failure were calculated for both the modified MSIS criteria and frozen sections.
At the time of second-stage reimplantation surgery, frozen section is useful in ruling in infection, where the specificity is 94% (95% confidence interval [CI], 89%-99%); however, there is less utility in ruling out infection, because sensitivity is only 50% (CI, 13%-88%). Both the MSIS criteria and frozen sections have high specificity for ruling in failure of reimplantation (MSIS criteria specificity: 96% [CI, 91%-100%]; frozen section: 95% [CI, 88%-100%]), but screening capabilities are limited (MSIS sensitivity: 26% [CI, 9%-44%]; frozen section: 22% [CI, 9%-29%]). Positive MSIS criteria at the time of reimplantation were a risk factor for subsequent failure (hazard ratio [HR], 5.22 [1.64-16.62], p = 0.005), whereas positive frozen section was not (HR, 1.16 [0.15-8.86], p = 0.883).
On the basis of our results, both frozen section and MSIS are recommended at the time of the second stage of revision arthroplasty. Both frozen section and modified MSIS criteria had limited screening capabilities to identify failure, although both demonstrated high specificity. MSIS criteria should be evaluated at the second stage of revision arthroplasty because performing reimplantation in a joint that is positive for infection significantly increases the risk for subsequent failure.
Level III, diagnostic study.
尽管关于冰冻切片组织学在翻修关节成形术第二阶段辅助诊断假体周围关节感染方面的数据有限,但它仍被广泛应用。此外,在再次植入时,尚无确定的方法来评估感染的控制情况。由于两阶段翻修失败可能会产生严重后果,因此识别可能失败的病例并在必要时推迟再次植入非常重要。因此,需要一种可靠的检测方法来提供有关感染控制情况和后续失败风险的信息。
问题/目的:(1)在第二阶段再次植入手术中,与作为金标准的肌肉骨骼感染协会(MSIS)标准相比,冰冻切片的诊断准确性如何?(2)MSIS标准和冰冻切片在预测再次植入失败方面的诊断准确性参数是什么?(3)再次植入时MSIS标准阳性或冰冻切片阳性是否会增加后续失败的风险?
2013年共有97例因诊断为假体周围关节感染(PJI)而接受全髋关节翻修术或全膝关节翻修术第二阶段手术的患者被认为符合该研究的条件。其中,11例不符合MSIS标准,7例缺乏1年随访,剩余79例患者(38例膝关节和41例髋关节)可供分析。在再次植入时,将冰冻切片结果与改良MSIS标准作为检测感染的金标准进行比较。随后,再次植入的成功或失败定义为:(1)感染得到控制,表现为伤口愈合,无瘘管、引流或疼痛;(2)再次植入手术后无需因感染进行后续手术干预;(3)未发生与PJI相关的死亡;并计算改良MSIS标准和冰冻切片在预测治疗失败方面的诊断参数。
在第二阶段再次植入手术时,冰冻切片有助于确诊感染,其特异性为94%(95%置信区间[CI],89%-99%);然而,在排除感染方面作用较小,因为敏感性仅为50%(CI,13%-88%)。MSIS标准和冰冻切片在确诊再次植入失败方面均具有较高的特异性(MSIS标准特异性:96%[CI,91%-100%];冰冻切片:95%[CI,88%-100%]),但筛查能力有限(MSIS敏感性:26%[CI,9%-44%];冰冻切片:22%[CI,9%-29%])。再次植入时MSIS标准阳性是后续失败的一个危险因素(风险比[HR],5.22[1.64-16.62],p = 0.005),而冰冻切片阳性则不是(HR,1.16[0.15-8.86],p = 0.883)。
根据我们的结果,在翻修关节成形术第二阶段推荐同时使用冰冻切片和MSIS标准。尽管冰冻切片和改良MSIS标准在识别失败方面的筛查能力有限,但两者均显示出较高的特异性。在翻修关节成形术第二阶段应评估MSIS标准,因为在感染阳性的关节中进行再次植入会显著增加后续失败的风险。
III级,诊断性研究。