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

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ClinicalTrials.gov Identifier: NCT02424903
Recruitment Status : Unknown
Verified April 2015 by Pro-Implant Foundation.
Recruitment status was:  Not yet recruiting
First Posted : April 23, 2015
Last Update Posted : April 23, 2015
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Pro-Implant Foundation

Brief Summary:
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.

Condition or disease
Prosthesis-related Infections

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Prosthetic Joint Infection Cohort Study (EPJIC): Evaluation of the Treatment Approach for Hip, Knee and Shoulder Prosthetic Joint Revision Surgery
Study Start Date : May 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort
with prosthetic joint infection
Patients admitted for a septic revision surgery
without prosthetic joint infection
Patients admitted for an aseptic revision surgery



Primary Outcome Measures :
  1. Infection outcome [ Time Frame: 12 months after surgery ]
    The infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening).


Secondary Outcome Measures :
  1. Functional outcome [ Time Frame: 12 months after surgery ]
    by HARRIS HIP SCORE, CONSTANT SHOULDER SCORE, KNEE SOCIETY SCORE, OXFORD HIP SCORE, OXFORD KNEE SCORE, QUICK DASH SCORE

  2. lifequality evaluation [ Time Frame: 12 months after surgery ]
    by EQ5D5l-score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients admitted to hospital
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02424903


Contacts
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Contact: Maren Engel +4930450652417 maren.engel@charite.de
Contact: Alessandra Catalina Bardelli +4930450552407 alessandra-catalina.bardelli@charite.de

Locations
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Germany
Charité, Berlin Not yet recruiting
Berlin, Germany, 13353
Contact: Maren Engel    +4930450652417    maren.engel@charite.de   
Contact: Alessandra Catalina Bardelli    +4930450552407    alessandra-catalina.bardelli@charite.de   
Principal Investigator: Andrej Trampuz         
Sponsors and Collaborators
Pro-Implant Foundation
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Andrej Trampuz Charite University, Berlin, Germany

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Responsible Party: Pro-Implant Foundation
ClinicalTrials.gov Identifier: NCT02424903     History of Changes
Other Study ID Numbers: PJI04/2014
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015

Keywords provided by Pro-Implant Foundation:
infection
prosthesis
hip
knee
shoulder

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Prosthesis-Related Infections
Postoperative Complications
Pathologic Processes