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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):

November 25, 2017
December 7, 2017
December 7, 2017
January 1, 2018
December 1, 2019   (Final data collection date for primary outcome measure)
  • 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
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Diagnosis of Periprosthetic Joint Infection and the Common Pathogens, Durg-resistance in Periprosthetic Joint Infection
Diagnosis of Periprosthetic Joint Infection and the Common Pathogens, Durg-resistance in Periprosthetic Joint Infection
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

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.

Observational
Observational Model: Case-Control
Time Perspective: Retrospective
Not Provided
Retention:   None Retained
Description:
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.
Non-Probability Sample
Patient who underwent revision or re-revision total hip or knee arthroplasty for different reasons in our institution
  • Arthropathy of Hip
  • Arthropathy of Knee
  • Other: Periprosthetic Joint Infection
    Periprosthetic Joint Infection is diagnosed according to the diagnosing criteria from the Workgroup of the Musculoskeletal Infection Society.
  • 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.
  • infectious group
    Patients who met the criteria according of Periprosthetic Joint Infection were identified as the infectious group.
    Intervention: Other: Periprosthetic Joint Infection
  • non-infectious group
    Patients who didn't meet the criteria according of Periprosthetic Joint Infection were identified as the non-periprosthetic joint infection group.
    Intervention: Other: Non-Periprosthetic Joint Infection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
160
December 1, 2019
December 1, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years to 70 Years   (Adult, Senior)
No
Contact: Zhanglai Li +86 17801099200 847869561@qq.com
Not Provided
 
 
NCT03365323
PKUPHACRC3
No
Not Provided
Plan to Share IPD: No
Lin Jianhao, Peking University People's Hospital
Peking University People's Hospital
Not Provided
Principal Investigator: Jianhao Lin arthritis and clinic and research center
Peking University People's Hospital
December 2017