Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2015 by Assistance Publique Hopitaux De Marseille
Sponsor:
Assistance Publique Hopitaux De Marseille
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01957228
First received: September 30, 2013
Last updated: August 31, 2015
Last verified: August 2015
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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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01957228
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 | 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
| 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: | August 31, 2015 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament et des produits de santé |
Additional relevant MeSH terms:
|
Infection Communicable Diseases Arthritis, Infectious |
Arthritis Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on September 29, 2016