Diagnosis of Periprosthetic Joint Infection and the Common Pathogens, Durg-resistance in Periprosthetic Joint Infection
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|ClinicalTrials.gov Identifier: NCT03365323|
Recruitment Status : Not yet recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment|
|Arthropathy of Hip Arthropathy of Knee||Other: Periprosthetic Joint Infection Other: Non-Periprosthetic Joint Infection|
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 Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Diagnosis of Periprosthetic Joint Infection and the Common Pathogens, Durg-resistance in Periprosthetic Joint Infection|
|Estimated Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Patients who met the criteria according of Periprosthetic Joint Infection were identified as the infectious group.
Other: Periprosthetic Joint Infection
Periprosthetic Joint Infection is diagnosed according to the diagnosing criteria from the Workgroup of the Musculoskeletal Infection Society.
Patients who didn't meet the criteria according of Periprosthetic Joint Infection were identified as the non-periprosthetic joint infection group.
Other: Non-Periprosthetic Joint Infection
PJI can not be diagnosed for the lack of clinical evidence according to the diagnosing criteria from the Workgroup of the Musculoskeletal Infection Society.
- 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 ESR [ Time Frame: within 4 weeks before the operation ]To test the specifity and sensitivity of ESR
- 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
- Microorganisms identification and the [ Time Frame: within 4 weeks before the operation ]Identify microorganisms causing periprosthetic joint infection (PJI) as well as the drug-resistant spectrum.
- Drug-resistant spectrum. [ Time Frame: within 4 weeks before the operation ]Identify the drug-resistant spectrum of the microorganisms.
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365323
|Contact: Zhanglai Li||+86 firstname.lastname@example.org|
|Principal Investigator:||Jianhao Lin||arthritis and clinic and research center|