| NCT ID | NCT02801253 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Groupe Hospitalier Diaconesses Croix Saint-Simon |
| Condition | Prosthetic Joint Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2015-09-11 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2015-09-11 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
VALERIE ZELLER, Doctorate
PRINCIPAL INVESTIGATOR
Groupe Hospitalier Diaconesses Croix Saint-Simon
Frequently Asked Questions
Who can join the NCT02801253 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prosthetic Joint Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02801253 currently recruiting?
Yes, NCT02801253 is actively recruiting participants. Contact the research team at ykerroumi@hopital-dcss.org for enrollment information.
Where is the NCT02801253 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT02801253 clinical trial?
NCT02801253 is sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon. The principal investigator is VALERIE ZELLER, Doctorate at Groupe Hospitalier Diaconesses Croix Saint-Simon. The trial plans to enroll 800 participants.