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

Study Overview

• Status: Unknown
• Conditions: Arthropathy of Knee; Arthropathy of Hip
• Intervention / Treatment: 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
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Zhanglai Li; Phone Number: +86 17801099200; Email: 847869561@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation the specific and sensitivity of CRP	To test the specifity and sensitivity of CRP	within 4 weeks before the operation
Evaluation the specific and sensitivity of ESR	To test the specifity and sensitivity of ESR	within 4 weeks before the operation
Evaluation the specific and sensitivity of synovial leukocyte counts	To test the specifity and sensitivity of synovial leukocyte counts	within 4 weeks before the operation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Jianhao Lin, arthritis and clinic and research center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: November 25, 2017
• First Submitted That Met QC Criteria: December 2, 2017
• First Posted (ACTUAL): December 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 2, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Periprosthetic Joint Infection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Infections; Joint Diseases
• Other Study ID Numbers: PKUPHACRC3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO