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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Prosthetic Joint Infections

Treatments: Procedure: bone biopsies

Study type: Interventional

Funder types: Other

Identifiers

NCT01957228

2013-A00960-45

2013-28 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 980 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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980 participants in 1 patient group

bone biopsies

Experimental group

Treatment:

Procedure: bone biopsies