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

This study is not yet open for participant recruitment.
Verified September 2013 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01957228
First received: September 30, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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 Intervention
Prosthetic Joint Infections
Procedure: bone biopsies

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Bone biopsies multisite [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Increase of at least 6% of patients with an etiologic diagnosis of prosthesis infection established.


Estimated Enrollment: 480
Study Start Date: October 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bone biopsies Procedure: bone biopsies

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01957228

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

Locations
France
Assistance Publique Hopitaux de Marseille Not yet 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

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01957228     History of Changes
Other Study ID Numbers: 2013-A00960-45, 2013-28
Study First Received: September 30, 2013
Last Updated: September 30, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on April 16, 2014