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Clinical Trials/NCT01957228
NCT01957228
Completed
Not Applicable

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

Assistance Publique Hopitaux De Marseille1 site in 1 country980 target enrollmentOctober 7, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prosthetic Joint Infections
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
980
Locations
1
Primary Endpoint
Bone biopsies multisite
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 7, 2013
End Date
October 26, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Bone biopsies multisite

Time Frame: 4 years

Increase of at least 6% of patients with an etiologic diagnosis of prosthesis infection established.

Study Sites (1)

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