European Prosthetic Joint Infection Cohort Study- Hip, Knee and Shoulder Prosthetic Joint Infection

NCT ID: NCT02424903

Last Updated: 2015-04-23

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

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-12-31

Brief Summary

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The purpose of the study is to compare different approaches for the treatment of prosthetic joint revisions and to optimize the outcomes in patients with prosthetic joint infections (PJI) by improving the treatment concept of PJI.

Detailed Description

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The aim of the study is to assess the impact of different surgical and antibiotic therapies on patients admitted for a septic or aseptic revision of the hip, knee or shoulder prosthesis. The decision whether the implant will be retained or removed or antimicrobial treatment is based on criteria of each participating center specialists.The success of different treatment algorithms will be measured in terms of infection free interval, functional outcome and quality of life. All consecutive patients who need a revision surgery to the hip, knee or shoulder will be included. Furthermore the study will investigate different diagnostic tests (microbiological and histological) for the diagnosis and the discrimination of septic and aseptic causes in prosthesis failures. Pathogens (microorganisms isolated from puncture of the joint, tissue samples sonication fluid and blood) will be collected to establish a biobank.The samples are obtained preoperatively and intraoperatively as part of routine care practice. The study is not randomized.

Conditions

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Prosthesis-related Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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with prosthetic joint infection

Patients admitted for a septic revision surgery

No interventions assigned to this group

without prosthetic joint infection

Patients admitted for an aseptic revision surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* subject is older than 18 years of Age
* written informed consent has been obtained
* subject Needs a Revision surgery of the hip, knee or shoulder prosthesis

Exclusion Criteria

* subject is currently enrolled in another investigational study
* inability to read and understand the participant's Information
* subject is younger than 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Pro-Implant Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrej Trampuz

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité, Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Central Contacts

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Maren Engel

Role: CONTACT

+4930450652417

Alessandra Catalina Bardelli

Role: CONTACT

+4930450552407

Facility Contacts

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Maren Engel

Role: primary

+4930450652417

Alessandra Catalina Bardelli

Role: backup

+4930450552407

Other Identifiers

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PJI04/2014

Identifier Type: -

Identifier Source: org_study_id

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