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临床试验/NCT04622280
NCT04622280已完成不适用

Prospectively Observational Evaluation of Clinical Outcomes in Two-stage Reimplantation for Infected Knee Arthroplasty Patients

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
infection eradication

研究概览

简要总结

Total knee arthroplasty (TKA) infection is a complication requiring multiple hospitalizations, operations, and outpatient visits placing a significant burden on both patient and treating surgeons. When revision surgery is needed, two kinds of treatment can be applied----one-stage and two-stage reimplantation procedure. The two-stage reimplantation procedure is considered the gold standard for treatment of subacute and chronic deep periprosthetic infections. Placement of antibiotic-loaded spacer is a standard procedure for eradication of peri-prosthetic joint infection. For better patient outcome, the purpose of this study was to determine the success rate of total knee infection patients treating with two-stage reimplantation procedure.

详细描述

*Background and study aims: Total knee arthroplasty (TKA) infection is a devastating complication requiring multiple hospitalizations, operations, and outpatient visits placing a significant burden on both patients and treating surgeons. The incidence of prosthetic joint infection after primary hip or knee arthroplasty is about 2% among the Medicare population. When revision surgery is needed, two kinds of treatment include one-stage and two-stage re-implantation procedure can be applied. Bengtsonet al., in an earlier report, evaluated 107 patients with a 75.7% success rate after one-stage revision. In the case of two-stage TKA revision success rates of 89% to 100% are noted with follow-up periods of 2 to 7.5 years. Delayed re-implantation after administration of intravenous antibiotics appears to offer better success rates than direct-exchange techniques. Therefore, the two-stage re-implantation procedure is considered the gold standard for treatment of subacute and chronic deep prosthetic joint infections (PJI). However, the protocols of the antibiotic therapy after resection arthroplasty have varied in different reports. The purpose of this study will be to evaluate the clinical outcomes of two-stage re-implantation for infected knee arthroplasty using the standardized protocol of combined parenteral and oral antibiotic therapy and the criterion for re-implantation.

*Study participants

Study period: from March 2011 to June 2019.

*Procedures and operations

-The first stage The first stage consisted of the removal of the prosthesis and all hardware, debridement of all infected and devitalized tissues, removal of all biofilms, and aqueous povidone iodine irrigation. For primary joint arthroplasty with cement, all the bone cement was removed. Samples for culture and histology were performed at the time of removal of prosthesis (ROP). The Long-leg splint was applied to the limb until the next replacement procedure. The first stage was using antibiotic-impregnated bone cement as a static spacer block. The types of antibiotic regimens were determined according to the results of cultures form the preoperative joint aspirations. In this study, 1 to 2 g of vancomycin (for gram-positive bacteria) and/or 1 to 2 g of ceftazidime (for gram-negative bacteria) per 40g package of cement would be hand-mixed according to the previous culture. Any past history of adverse events of the antibiotics used in the cement would be clarified to avoid any possible allergic reactions to the antibiotic-loaded cement. If the patient had allergic reactions to vancomycin or ceftazidime, daptomycin or gentamicin 1 to 2 g will be used for alternative antibiotic cement.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

infection eradication

时间窗: 2012-2019

without recurrent or persisted infection of the joint in one year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Statistical Center, NTUHCTC

National Taiwan University Hospital

National Taiwan University Hospital

研究点 (1)

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