NCT02801253

Cohort of Prosthetic Joint Infections

Prospective Cohort of Patients With Prosthetic Joint Infection

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Large prospective cohort study in a French referral center for bone and joint infections. Population * all patients who consented to participate in the study with PJI treated with: * debridement-synovectomy for acute infection * with one-stage, two-stage exchange arthroplasty for chronic infection * other procedures (complete removal of the prosthesis) and antibiotic therapy * patients (non-operated or operated) receiving prolonged suppressive antibiotic therapy Outcome: * Follow-up at least 2 years * Events monitored: reinfection including relapse and new infection, joint revision for mechanical failure, PJI related or non-related death Study duration: 10 years. Recruitment period: 4 years. Maximal duration of data collection: 6 years. Investigator center: monocenter study. Mean patient inclusion per year: 100 patients per year.

Conditions

• Prosthetic Joint Infection

Timeline

• Start date: 2015-09-11
• Primary completion: 2025-09-01
• Completion: 2029-09-01
• First posted: 2016-06-15
• Last updated: 2022-03-29

Locations

1 site across 1 country: France