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

Prosthetic Joint Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957228
• Other study ID #: 2013-A00960-45
• Secondary ID: 2013-28
• Status: Completed
• Phase: N/A
• Start date: October 7, 2013
• Est. completion date: October 26, 2022

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 980
• Est. completion date: October 26, 2022
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infections
• Prosthetic Joint Infections

Intervention

Procedure:
• bone biopsies

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone biopsies multisite	Increase of at least 6% of patients with an etiologic diagnosis of prosthesis infection established.	4 years