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

Arthropathy of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03365323
• Other study ID #: PKUPHACRC3
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2017
• Last updated: December 2, 2017
• Start date: January 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: Zhanglai Li
• Phone: +86 17801099200
• Email: 847869561[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Infectious
• Arthropathy of Hip
• Arthropathy of Knee
• Infection
• Joint Diseases

Intervention

Other:
• Periprosthetic Joint Infection
Periprosthetic Joint Infection is diagnosed according to the diagnosing criteria from the Workgroup of the Musculoskeletal Infection Society.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation the specific and sensitivity of CRP	To test the specifity and sensitivity of CRP	within 4 weeks before the operation
Primary	Evaluation the specific and sensitivity of ESR	To test the specifity and sensitivity of ESR	within 4 weeks before the operation
Primary	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	Microorganisms identification and the	Identify microorganisms causing periprosthetic joint infection (PJI) as well as the drug-resistant spectrum.	within 4 weeks before the operation
Secondary	Drug-resistant spectrum.	Identify the drug-resistant spectrum of the microorganisms.	within 4 weeks before the operation