Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection

Diagnosis Prosthetic Joint Infection Clinical Trial

— SyPJI  

Official title:

Benefit of Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03038464
• Other study ID #: 445/21
• Status: Recruiting
• Phase: N/A
• First received: January 30, 2017
• Last updated: April 24, 2017
• Start date: November 1, 2016
• Est. completion date: May 1, 2019

Study information

• Verified date: January 2017
• Source: Technische Universität München
• Contact: norbert harrasser
• Phone: 15232716657
• Email: norbert.harrasser[@]gmx.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The two-stage protocol is gold standard in terms of infection control treating prosthetic joint infections of total hip and total knee arthroplasty. The antibiotic pause for diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of infection and development of resistant bacterial strains. Serological markers and synovial analysis are common use to exclude persistence of infection.

The investigators therefore asked 1) is the serological testing of c-reactive protein and leukocytes a valuable tool to predict a persistence of infection and 2) what is the role of synovial aspiration of PMMA Spacers on hip and knee joints.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with periprostheitc joint infection

Exclusion Criteria:

• Reinfection in history

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Diagnosis Prosthetic Joint Infection
• Infection

Intervention

Diagnostic Test:
• Synovial biopsy
Biopsy of jint prior reimplantation of new joint prosthesis

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reinfection rate	Reinfection rate after reimplantation of joint prosthesis	2 years