Informations générales (source: ClinicalTrials.gov)
Prospective Cohort of Patients With Prosthetic Joint Infection
Observational
Groupe Hospitalier Diaconesses Croix Saint-Simon (Voir sur ClinicalTrials)
septembre 2015
septembre 2029
18 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Younes KERROUMI, Doctorate | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- Patient who does not meet eligibility criteria.
- Patient lawfully deprived of his liberty.
- Patient not insured under social security scheme.