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CompletedNCT01957228Updated Apr 21, 2023

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

An interventional study of bone biopsies in Prosthetic Joint Infections, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
980
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 980 is above the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patient minor (\<18 years).
  • Pregnant or lactating woman.
  • Major under guardianship Patient.
  • Patient deprived of liberty or under court order
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
980 participants (actual)

Study arms

  • Experimental
    bone biopsies

    Procedure: bone biopsies

Interventions

  • Procedurebone biopsies
06

What researchers measure

Primary outcomes

  1. Bone biopsies multisite

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

    Time frame: 4 years

07

Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01957228
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Oct 8, 2013
Start date
Oct 7, 2013
Primary completion
Sep 30, 2019
Completion
Oct 26, 2022
Last update
Apr 21, 2023

Study contacts

LOIC MONDOLONI
study director · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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