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

• Conditions: Arthropathy of Knee; Arthropathy of Hip
• Interventions: Other: Non-Periprosthetic Joint Infection; Other: Periprosthetic Joint Infection

• Registration Number: NCT03365323
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study First Submitted: 2017-11-25
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-02
• Last Update Submitted: 2017-12-02
• Study First Posted: 2017-12-07
• Last Update Posted: 2017-12-07
• Study Start: 2018-01-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-infectious group	Non-Periprosthetic Joint Infection	Patients who didn't meet the criteria according of Periprosthetic Joint Infection were identified as the non-periprosthetic joint infection group.
infectious group	Periprosthetic Joint Infection	Patients who met the criteria according of Periprosthetic Joint Infection were identified as the infectious group.

Primary Outcome Measures

Name	Time	Method
Evaluation the specific and sensitivity of CRP	within 4 weeks before the operation	To test the specifity and sensitivity of CRP
Evaluation the specific and sensitivity of synovial leukocyte counts	within 4 weeks before the operation	To test the specifity and sensitivity of synovial leukocyte counts
Evaluation the specific and sensitivity of ESR	within 4 weeks before the operation	To test the specifity and sensitivity of ESR

Secondary Outcome Measures

Name	Time	Method
Drug-resistant spectrum.	within 4 weeks before the operation	Identify the drug-resistant spectrum of the microorganisms.
Microorganisms identification and the	within 4 weeks before the operation	Identify microorganisms causing periprosthetic joint infection (PJI) as well as the drug-resistant spectrum.