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

NCT03365323 | Unknown

• 1 other identifier: PKUPHACRC3
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

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

Conditions

Arthropathy of Hip; Arthropathy of Knee

Keywords

Periprosthetic Joint Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Microorganisms identification and the

  within 4 weeks before the operation

• Drug-resistant spectrum.

  within 4 weeks before the operation

Study Arms (2)

infectious group

Patients who met the criteria according of Periprosthetic Joint Infection were identified as the infectious group.

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.

Other: Non-Periprosthetic Joint Infection

Interventions

Periprosthetic Joint Infection OTHER

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

infectious group

Non-Periprosthetic Joint Infection OTHER

PJI can not be diagnosed for the lack of clinical evidence according to the diagnosing criteria from the Workgroup of the Musculoskeletal Infection Society.

non-infectious group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• patient who underwent revision or re-revision total hip or knee arthroplasty for different reasons in our institution

You may not qualify if:

• Patients who refused to join the trial group;
• Revision total hip/knee replacement for periprosthetic fracture;
• patients who missed some of important examination;
• Revision total hip/knee replacement for metal sensitivity;
• Revision total hip/knee replacement for the last period of second-stage revision;
• Patient who underwent revision with RA or other inflammatory disease.

Sponsors & Collaborators

• Peking University People's Hospital: lead

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.

Study Officials

• Jianhao Lin

  arthritis and clinic and research center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhanglai Li

CONTACT

+86 17801099200; 847869561@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The clinical professor of arthritis clinic and research center

Study Record Dates

• First Submitted: November 25, 2017
• First Posted: December 7, 2017
• Study Start: January 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 7, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share