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Clinical Trials in France / NCT02801253
Recruiting Observational

Cohort of Prosthetic Joint Infections

NCT02801253 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2015-09-11
Last updated
2022-03-29

Condition(s) studied

Prosthetic Joint Infection

Study summary

Management of prosthetic joint infections (PJI) is a challenging task. These infections include different clinical and microbiological settings calling upon various treatment strategies according to infection type (acute or chronic), bone quality, the involved micro-organism and the patient's general condition and willing.

Treatment of PJI combines surgery and prolonged antibiotic therapy. In some patients with a high operative risk prolonged suppressive antibiotic therapy can be used.

Lack of large prospective studies motivated the conception of this cohort with a long term follow up, regardless to PJI management procedures.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient aged over 18 years old with hip, knee and or shoulder joint prosthesis who consented to participate in the study with: * According to musculoskeletal infection society definition: PJI is present when one of the major criteria exists or four out of six minor criteria. Major Criteria: * Two positive periprosthetic cultures with phenotypically identical organisms, OR * A sinus tract communicating with the joint, OR Minor Criteria: * Elevated serum C-reactive protein (CRP) AND erythrocyte sedimentation rate (ESR) * Elevated synovial fluid white blood cell (WBC) * Elevated synovial fluid polymorphonuclear neutrophil percentage (PMN%) * The presence of pus in the joint without known cause * Positive histological analysis of periprosthetic tissue * A single positive culture Or a PJI which meets the following three criteria: * Medical story suggesting prosthetic joint infection. * The presence of pain either with or without swelling for more than 3 months unrelated to a mechanical cause. * Germ identification in a single sample of fluid aspiration or tissue culture. * Or microbial growth in prosthesis sonication fluid culture greater than 50CFU/ml. Exclusion Criteria: * Patient who does not meet eligibility criteria. * Patient lawfully deprived of his liberty. * Patient not insured under social security scheme.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Groupe Hospitalier Diaconesses Croix Saint Simon Paris Île-de-France Region Recruiting

More Groupe Hospitalier Diaconesses Croix Saint-Simon trials in France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02801253 on ClinicalTrials.gov ↗ ← All trials in France