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Clinical Trials/NCT03365323
NCT03365323
Unknown
Not Applicable

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

Peking University People's Hospital0 sites160 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthropathy of Hip
Sponsor
Peking University People's Hospital
Enrollment
160
Primary Endpoint
Evaluation the specific and sensitivity of CRP
Last Updated
8 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 1, 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lin Jianhao

The clinical professor of arthritis clinic and research center

Peking University People's Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Evaluation the specific and sensitivity of CRP

Time Frame: within 4 weeks before the operation

To test the specifity and sensitivity of CRP

Evaluation the specific and sensitivity of synovial leukocyte counts

Time Frame: within 4 weeks before the operation

To test the specifity and sensitivity of synovial leukocyte counts

Evaluation the specific and sensitivity of ESR

Time Frame: within 4 weeks before the operation

To test the specifity and sensitivity of ESR

Secondary Outcomes

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

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