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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

About this trial

This is an interventional diagnostic trial for Prosthetic Joint Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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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