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Trial record 9 of 50 for:    "Prosthetic Joint Infection"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Harrasser, Technische Universität München

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.

Condition or disease Intervention/treatment
Diagnosis Prosthetic Joint Infection Diagnostic Test: Synovial biopsy

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Reinfection rate [ Time Frame: 2 years ]
    Reinfection rate after reimplantation of joint prosthesis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with periprostheitc joint infection

Inclusion Criteria:

  • Patients with periprostheitc joint infection

Exclusion Criteria:

  • Reinfection in history

Information from the National Library of Medicine

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 identifier (NCT number): NCT03038464

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Contact: norbert harrasser 15232716657

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Klinikum rechts der Isar Recruiting
Munich, Bavaria, Germany, 81675
Contact: Norbert Harrasser, DR.    00498941405229   
Contact: Ingo Banke, Dr.    00498941405284   
Sponsors and Collaborators
Technische Universität München

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Responsible Party: Harrasser, Principal Investigator, Technische Universität München Identifier: NCT03038464     History of Changes
Other Study ID Numbers: 445/21
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Arthritis, Infectious
Joint Diseases
Musculoskeletal Diseases