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Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy
This study is currently recruiting participants.
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 ]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) |
| 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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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 ( Other Identifier: AP HM ) |
| Study First Received: | September 30, 2013 |
| Last Updated: | August 31, 2015 |
Additional relevant MeSH terms:
|
Infection Communicable Diseases Arthritis, Infectious |
Arthritis Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 23, 2017