Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy
|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
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.
Evaluate the effectiveness of the new diagnostic strategy on etiological identification of prosthesis infections.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: bone biopsies||
Procedure: bone biopsies
- Bone biopsies multisite [ Time Frame: 4 years ]Increase of at least 6% of patients with an etiologic diagnosis of prosthesis infection established.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957228
|Contact: andreas email@example.com|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: andreas stein firstname.lastname@example.org|
|Principal Investigator: andreas stein|
|Study Director:||LOIC MONDOLONI||Assistance Publique Hopitaux De Marseille|