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Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy

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ClinicalTrials.gov Identifier: NCT01957228
Recruitment Status : Unknown
Verified August 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : October 8, 2013
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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Brief Summary:

On joint orthopaedic hardware infections are one of the most frequently encountered complications in orthopaedic surgery. However 6% of the cultures remain sterile, etiological diagnosis cannot be established despite obvious signs of infection. As part of this research project, we have developed a new strategy diagnosis including directly the use of PCR to reduce the number of negative results. This should have a major therapeutic impact in terms of timeliness and specificity of antibiotic.

Primary:

Evaluate the effectiveness of the new diagnostic strategy on etiological identification of prosthesis infections.

Hypothesis:

Minimum 6 percent increase in the number of patients with an etiological diagnosis of infection on prosthesis.


Condition or disease Intervention/treatment Phase
Prosthetic Joint Infections Procedure: bone biopsies Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy
Study Start Date : October 2013
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: bone biopsies Procedure: bone biopsies


Outcome Measures
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Primary Outcome Measures :
  1. Bone biopsies multisite [ Time Frame: 4 years ]
    Increase of at least 6% of patients with an etiologic diagnosis of prosthesis infection established.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is more than 18 years old.
  • Patient with a prescription of a microbiologic diagnostic of Prosthetic joint infection
  • Patient who do not declined to have his medical records reviewed for research
  • Patient with health insurance

Exclusion Criteria:

  • Patient minor (<18 years).
  • Pregnant or lactating woman.
  • Major under guardianship Patient.
  • Patient deprived of liberty or under court order
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01957228


Contacts
Contact: andreas stein andreas.stein@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: andreas stein       andreas.stein@ap-hm.fr   
Principal Investigator: andreas stein         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01957228     History of Changes
Other Study ID Numbers: 2013-A00960-45
2013-28 ( Other Identifier: AP HM )
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Infection
Communicable Diseases
Arthritis, Infectious
 Arthritis
Joint Diseases
Musculoskeletal Diseases