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

NCT ID: NCT03038464

Last Updated: 2017-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-01

Study Completion Date

2019-05-01

Brief Summary

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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

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Conditions

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Diagnosis Prosthetic Joint Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Synovial biopsy

Biopsy of jint prior reimplantation of new joint prosthesis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with periprostheitc joint infection

Exclusion Criteria

* Reinfection in history
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Harrasser

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Klinikum rechts der Isar

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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norbert harrasser

Role: CONTACT

15232716657

Facility Contacts

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Norbert Harrasser, DR.

Role: primary

00498941405229

Ingo Banke, Dr.

Role: backup

00498941405284

Other Identifiers

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445/21

Identifier Type: -

Identifier Source: org_study_id

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