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

• Conditions: Diagnosis Prosthetic Joint Infection

• Registration Number: NCT03038464
• Lead Sponsor: Technical University of Munich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-01
• Status Verified: 2017-01
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-01-31
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25
• Primary Completion: 2019-04-01
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with periprostheitc joint infection

Exclusion Criteria

• Reinfection in history

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reinfection rate	2 years	Reinfection rate after reimplantation of joint prosthesis

Trial Locations

Locations (1)

Klinikum rechts der Isar; 🇩🇪 Munich, Bavaria, Germany