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
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.
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
|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|