Cohort of Prosthetic Joint Infections

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Cohort of Patients With Prosthetic Joint Infection

Conditions
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Prosthetic Joint Infection

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of joint function at one, two, four and 6 years after prosthesis revision with one or two stage exchange arthroplasty. |  | 1, 2, 4, 6 years | 
| Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty |  | 6 years | 
| Assessment of treatment failure rate in patients with hip and knee PJI 2 years after prolonged suppressive antibiotic therapy in non-operated patients. |  | 2 years | 
| Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty. |  | 2 years |