Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy

NCT ID: NCT01957228

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

980 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-07

Study Completion Date

2022-10-26

Brief Summary

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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.

Detailed Description

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Conditions

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Prosthetic Joint Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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bone biopsies

Group Type EXPERIMENTAL

bone biopsies

Intervention Type PROCEDURE

Interventions

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bone biopsies

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LOIC MONDOLONI

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2013-28

Identifier Type: OTHER

Identifier Source: secondary_id

2013-A00960-45

Identifier Type: -

Identifier Source: org_study_id

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