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Cohort of Prosthetic Joint Infections

Cohort of Prosthetic Joint Infections

Recruiting
18 years and older
All
Phase N/A

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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.

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.

Eligibility

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.

Study details
    Prosthetic Joint Infection

NCT02801253

Groupe Hospitalier Diaconesses Croix Saint-Simon

26 January 2024

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