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Идёт набор NCT02801253

Cohort of Prosthetic Joint Infections

— Наблюдательное Prosthetic Joint Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Prosthetic Joint Infection. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective Cohort of Patients With Prosthetic Joint Infection

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors [Срок оценки: 2 years]
Вторичные конечные точки (4)
  • Assessment of joint function at one, two, four and 6 years after prosthesis revision with one or two stage exchange arthroplasty. [Срок оценки: 1, 2, 4, 6 years]
  • Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty [Срок оценки: 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. [Срок оценки: 2 years]
  • Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty. [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • Patient who does not meet eligibility criteria.
  • Patient lawfully deprived of his liberty.
  • Patient not insured under social security scheme.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Groupe Hospitalier Diaconesses Croix Saint Simon — Paris

Идентификаторы

NCT: NCT02801253 · ID RCB: 2014-A01100-47

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗