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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
Sponsor:
Information provided by (Responsible Party):
Lin Jianhao, 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

Condition or disease Intervention/treatment
Arthropathy of Hip Arthropathy of Knee Other: Periprosthetic Joint Infection Other: Non-Periprosthetic Joint Infection

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 Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Group/Cohort Intervention/treatment
infectious group
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.

non-infectious group
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.




Primary Outcome Measures :
  1. Evaluation the specific and sensitivity of CRP [ Time Frame: within 4 weeks before the operation ]
    To test the specifity and sensitivity of CRP

  2. Evaluation the specific and sensitivity of ESR [ Time Frame: within 4 weeks before the operation ]
    To test the specifity and sensitivity of ESR

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. Drug-resistant spectrum. [ Time Frame: within 4 weeks before the operation ]
    Identify the drug-resistant spectrum of the microorganisms.


Biospecimen Retention:   None Retained
Collected lab examinations included blood routine test, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), synovial leukocyte counts, as well as microorganisms isolated from periprosthetic tissues and articular fluid.


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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who underwent revision or re-revision total hip or knee arthroplasty for different reasons in our institution
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Zhanglai Li +86 17801099200 847869561@qq.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
Principal Investigator: Jianhao Lin arthritis and clinic and research center

Responsible Party: Lin Jianhao, The clinical professor of arthritis clinic and research center, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03365323     History of Changes
Other Study ID Numbers: PKUPHACRC3
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lin Jianhao, Peking University People's Hospital:
Periprosthetic Joint Infection

Additional relevant MeSH terms:
Infection
Joint Diseases
Arthritis, Infectious
Musculoskeletal Diseases
Arthritis