Cohort of Prosthetic Joint Infections
Recruiting now
Conditions studied: Prosthetic Joint Infection
In brief
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.
Key facts
- Study ID
- NCT02801253
- Run by
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- People needed
- 800
- Starts
- 2015-09-11
- Expected to finish
- 2029-09-01
- Last updated by the study team
- 2022-03-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patient who does not meet eligibility criteria.
- Patient lawfully deprived of his liberty.
- Patient not insured under social security scheme.
Where it is running
- Groupe Hospitalier Diaconesses Croix Saint Simon — Paris, Île-de-France Region, France (enrolling)
Full record on ClinicalTrials.gov
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