Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01957228
Enrollment
980
Registered
2013-10-08
Start date
2013-10-07
Completion date
2022-10-26
Last updated
2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthetic Joint Infections

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.

Interventions

PROCEDUREbone biopsies

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Bone biopsies multisite4 yearsIncrease of at least 6% of patients with an etiologic diagnosis of prosthesis infection established.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026