Prosthetic Joint Infection
Conditions
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.
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.
Interventions
None listed
Sponsors
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Contacts
Primary ContactYOUNES KERROUMI, Doctorate
Outcome results
None listed