Меню
Идёт набор NCT07473089

Swiss Revision Cohort

Наблюдательное Joint (Knee or Hip Replacement) Infection as Complication of Medical Care

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
В протоколе указаны: Revision for periprosthetic joint infections of the hip, knee, shoulder, elbow or ankle.
Кому может быть актуально
Состояния в реестре: Joint (Knee or Hip Replacement), Infection as Complication of Medical Care. 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Swiss Revision Cohort: a Nationwide, Multi-center, Prospective Periprosthetic Joint Infection Cohort Study

Обзор

This study follows patients with infections after a joint replacement over time. During follow-up, treatment outcomes are carefully measured to determine whether the infection can be cured. In addition, factors that may change infection cure rates are examined, including the patient's overall health, the type of bacteria causing the infection, and the surgical and antibiotic treatments used. The goal is to understand what leads to more frequent cure and to improve future care.

Подробное описание

Diagnostic and therapeutic management of patients with periprosthetic joint infections (PJIs) remains challenging. Successful management of PJI requires revision surgery of the prosthetic joint. The Swiss National Joint Registry (SIRIS) reported two-year revision rates of 2.5% for total hip arthroplasty and 3.3% for total knee arthroplasty in 2023, with infection being the most frequent cause of early revision (27.9% for hips and 20.6% for knees). Despite published guidelines, the management of PJI remains insufficiently standardized, primarily due to heterogeneous clinical presentations and limited availability of rigorous data from prospective studies and randomized controlled trials comparing interventions to improve outcomes. The presence of foreign material with biofilm formation further complicates the diagnosis and treatment of PJI, posing a significant challenge for clinicians necessitating close collaboration among specialists from various medical fields, including orthopaedic surgeons, microbiologists and infectious disease experts. A recent observational study suggests that a multidisciplinary team approach is associated with improved diagnostics, fewer surgeries, reduced length of hospital stay, and higher success rates.

This national cohort aims to describe the epidemiology, clinical phenotypes, management strategies and outcomes of patients with PJI. This is a national, multicentre, prospective, longitudinal, observational cohort study of patients who underwent revision for PJI of the hip, knee, shoulder, elbow or ankle. Participating centres include university or non-university tertiary healthcare facilities located in Switzerland. Episodes include likely and confirmed PJI, as defined by the European Bone and Joint Infection Society (EBJIS) criteria. During routine clinical visits after revision surgery, data are collected and patients are followed-up thereafter for a minimum of two years. The primary objective is infection outcome and secondary objectives include functional outcome and patient satisfaction, and evaluation of host, infection, microbiological and treatment factors associated with treatment failure and poor functional outcomes, both in the overall population and across subgroups. A minimum of 329 patients would be needed to have sufficient statistical power to carry out these analyses.

Вмешательства

  • Процедура Revision for periprosthetic joint infections of the hip, knee, shoulder, elbow or ankle
    Participants who undergo revision surgery of a prosthetic hip, knee, shoulder, ankle, or elbow joint for suspected periprosthetic joint infection. A patient may contribute one or more episodes, which are defined as a condition leading to revision surgery for a suspected or confirmed periprosthetic joint infection.

Первичные конечные точки

  • Rate of infection failure [Срок оценки: Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.]
Вторичные конечные точки (8)
  • Mean of range of motion measurement (hip) [Срок оценки: Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.]
  • Mean of range of motion measurement (knee) [Срок оценки: Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.]
  • Percent using any analgesics [Срок оценки: Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.]
  • Percent using walking aids (for lower extremity) [Срок оценки: Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.]
  • Mean of EuroQol five-dimensional questionnaire score [Срок оценки: Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.]
  • Mean of subjective evaluation of pain [Срок оценки: Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.]
  • Percent of adverse events from antibiotic treatment [Срок оценки: Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.]
  • Percent requiring surgical intervention [Срок оценки: Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.]

Критерии участия

Критерии включения

  • ≥18 years of age
  • Revision surgery of any large prosthetic joint (i.e., hip, knee, shoulder, ankle, or elbow) performed for a suspected or confirmed periprosthetic joint infections at any of the participating study centres. This includes patients who were previously treated at another hospital and referred to a participating study centre if data on a transferred patient from the previous institution are available, complete, and archived in the institutional patient information system, and the patient underwent at least one surgery at a participating institution.
  • Obtained written informed consent
  • Periprosthetic joint infections diagnosis likely or confirmed according to European Bone and Joint Infection Society criteria

Критерии исключения

  • Documented objection to subsequent use of personal health data
  • Patient follow-up outside of Switzerland
  • Diagnosis "periprosthetic joint infections unlikely" according to European Bone and Joint Infection Society criteria

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 5 центров
  • Department of Infectious Diseases and Infection Prevention, Cantonal Hospital Aarau — Aarau
  • Department of Infectious Diseases, Bern University Hospital — Bern
  • Department of Medicine, HFR Fribourg-Hôpital Cantonal — Fribourg
  • Orthopedic Surgery Service, Geneva University Hospitals — Geneva
  • Department of Medicine, Lausanne University Hospital — Lausanne

Публикации

  • Vuorinen M, Makinen T, Rantasalo M, Huotari K. Effect of a multidisciplinary team on the treatment of hip and knee prosthetic joint infections: a single-centre study of 154 infections. Infect Dis (Lond). 2021 Sep;53(9):700-706. doi: 10.1080/23744235.2021.1925341. Epub 2021 Jun 1. PMID 34060985
  • Karczewski D, Winkler T, Renz N, Trampuz A, Lieb E, Perka C, Muller M. A standardized interdisciplinary algorithm for the treatment of prosthetic joint infections. Bone Joint J. 2019 Feb;101-B(2):132-139. doi: 10.1302/0301-620X.101B2.BJJ-2018-1056.R1. PMID 30700114
  • Osmon DR, Berbari EF, Berendt AR, Lew D, Zimmerli W, Steckelberg JM, Rao N, Hanssen A, Wilson WR; Infectious Diseases Society of America. Executive summary: diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013 Jan;56(1):1-10. doi: 10.1093/cid/cis966. PMID 23230301
  • Koh CK, Zeng I, Ravi S, Zhu M, Vince KG, Young SW. Periprosthetic Joint Infection Is the Main Cause of Failure for Modern Knee Arthroplasty: An Analysis of 11,134 Knees. Clin Orthop Relat Res. 2017 Sep;475(9):2194-2201. doi: 10.1007/s11999-017-5396-4. Epub 2017 Jun 1. PMID 28573549
  • Pallanza M, Ateschrang A, Boyd A, Conen A, Kritikos A, Laurencon J, Liechti EF, Meylan S, Pham TT, Steinmetz S, Suva D, Thurnheer MC, Renz N. Nationwide, multicentre, prospective periprosthetic joint infection cohort study: study protocol of the Swiss Revision Cohort (REVCO). BMJ Open. 2026 Jul 16;16(7):e120092. doi: 10.1136/bmjopen-2026-120092. PMID 42463213

Идентификаторы

NCT: NCT07473089 · 2021-01791

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗