Cohort of Prosthetic Joint Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prosthetic Joint Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Cohort of Patients With Prosthetic Joint Infection
Overview
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.
Primary outcome measures
- Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors [Time frame: 2 years]
Secondary outcome measures (4)
- Assessment of joint function at one, two, four and 6 years after prosthesis revision with one or two stage exchange arthroplasty. [Time frame: 1, 2, 4, 6 years]
- Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty [Time frame: 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. [Time frame: 2 years]
- Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty. [Time frame: 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Groupe Hospitalier Diaconesses Croix Saint Simon — Paris
Identifiers
NCT: NCT02801253 · ID RCB: 2014-A01100-47