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临床试验/NCT03365323
NCT03365323Unknown不适用

Diagnosis of Periprosthetic Joint Infection and the Common Pathogens, Durg-resistance in Periprosthetic Joint Infection

Peking University People's Hospital0 个研究点目标入组 160 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
主要终点
Evaluation the specific and sensitivity of CRP

研究概览

简要总结

This retrospective study aims to improve the diagnosis of PJI as well as to identify microorganisms causing periprosthetic joint infection (PJI) and the drug-resistant spectrum

详细描述

160 patients who underwent revision or re-revision total hip or knee arthroplasty for different reasons in our institution were recruited from August 2013 to August 2016. 80 patients meet the criteria of PJI from the muscle and skeletal muscle Association (MSIS) are divided to the infection group, another 80 patients are divided into the non-infection group.

Medical and demographic data were recorded. Collected lab examinations included blood routine test, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), synovial leukocyte counts, Receiver Operating Characteristic Curve-Area Under Curve (ROC-AUC) analysis will be used to evaluate the specific and sensitivity of diagnosis index. Moreover,microorganisms isolated from periprosthetic tissues and articular fluid. Postoperatively, the prosthesis was sent for ultrasound sonication. The sonicate extraction, implant surrounding tissue and synovium were sent for microbiologic culture, and the implant-surrounding-tissue were also sent for pathological examination. The isolated strains and drug-resistance rate for each bacterium for different antibiotics were presented.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient who underwent revision or re-revision total hip or knee arthroplasty for different reasons in our institution

排除标准

  • Patients who refused to join the trial group;
  • Revision total hip/knee replacement for periprosthetic fracture;
  • patients who missed some of important examination;
  • Revision total hip/knee replacement for metal sensitivity;
  • Revision total hip/knee replacement for the last period of second-stage revision;
  • Patient who underwent revision with RA or other inflammatory disease.

结局指标

主要结局

Evaluation the specific and sensitivity of CRP

时间窗: within 4 weeks before the operation

To test the specifity and sensitivity of CRP

Evaluation the specific and sensitivity of synovial leukocyte counts

时间窗: within 4 weeks before the operation

To test the specifity and sensitivity of synovial leukocyte counts

Evaluation the specific and sensitivity of ESR

时间窗: within 4 weeks before the operation

To test the specifity and sensitivity of ESR

次要结局

  • Drug-resistant spectrum.(within 4 weeks before the operation)
  • Microorganisms identification and the(within 4 weeks before the operation)

研究者

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

Lin Jianhao

The clinical professor of arthritis clinic and research center

Peking University People's Hospital

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