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

P

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)

980 participants in 1 patient group

bone biopsies
Experimental group
Treatment:
Procedure: bone biopsies

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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