Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection (SyPJI)
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|ClinicalTrials.gov Identifier: NCT03038464|
Recruitment Status : Unknown
Verified January 2017 by Harrasser, Technische Universität München.
Recruitment status was: Recruiting
First Posted : January 31, 2017
Last Update Posted : April 25, 2017
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.
|Condition or disease||Intervention/treatment|
|Diagnosis Prosthetic Joint Infection||Diagnostic Test: Synovial biopsy|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Benefit of Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection|
|Actual Study Start Date :||November 1, 2016|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||May 1, 2019|
- Diagnostic Test: Synovial biopsy
Biopsy of jint prior reimplantation of new joint prosthesis
- Reinfection rate [ Time Frame: 2 years ]Reinfection rate after reimplantation of joint prosthesis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038464
|Contact: norbert firstname.lastname@example.org|
|Klinikum rechts der Isar||Recruiting|
|Munich, Bavaria, Germany, 81675|
|Contact: Norbert Harrasser, DR. 00498941405229 email@example.com|
|Contact: Ingo Banke, Dr. 00498941405284 firstname.lastname@example.org|