Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy
Primary Purpose
Prosthetic Joint Infections
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bone biopsies
Sponsored by
About this trial
This is an interventional diagnostic trial for Prosthetic Joint Infections
Eligibility 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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bone biopsies
Arm Description
Outcomes
Primary Outcome Measures
Bone biopsies multisite
Increase of at least 6% of patients with an etiologic diagnosis of prosthesis infection established.
Secondary Outcome Measures
Full Information
NCT ID
NCT01957228
First Posted
September 30, 2013
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01957228
Brief Title
Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy
Official Title
Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 7, 2013 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Joint Infections
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
980 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bone biopsies
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
bone biopsies
Primary Outcome Measure Information:
Title
Bone biopsies multisite
Description
Increase of at least 6% of patients with an etiologic diagnosis of prosthesis infection established.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LOIC MONDOLONI
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy
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