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Идёт набор NCT05543941

Evaluating XPERIENCE™ Advanced Surgical Irrigation

Без фазы С лечением Hip Osteoarthritis Hip Arthritis Knee Osteoarthritis Knee Arthritis

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: XPERIENCE Advanced Surgical Irrigation, Dilute Betadine.
Кому может быть актуально
Состояния в реестре: Hip Osteoarthritis, Hip Arthritis, Knee Osteoarthritis, Knee Arthritis. 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
Канада
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

Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial

Обзор

A prospective, multi-center, double-arm, parallel, interventional, randomized, controlled clinical trial to assess the rate of periprosthetic joint infection (PJI) in patients undergoing primary total knee arthroplasty (TKA), total hip arthroplasty (THA) or hip resurfacing (HR) with XPERIENCE™ (XP) Advanced Surgical Irrigation versus dilute Betadine (DB).

Вмешательства

  • Устройство XPERIENCE Advanced Surgical Irrigation
    The patient will undergo THA, TKA, or HR with irrigation of the deep wound prior to fascial closure consisting of XPERIENCE Advanced Surgical Irrigation (XP). XP solution will be applied prior to fascial closure and left to soak for up to 3 minutes. Remaining product will be suctioned away throughout the procedure. No rinsing should take place after irrigation and surgical site will be closed according to site standard operating procedures.
  • Устройство Dilute Betadine
    The patient will undergo THA, HR or TKA with irrigation of the deep wound prior to fascial closure consisting of Dilute Betadine (DB). DB concentration will be standardized at 0.3% povidone-iodine. DB will be prepared by combining 30 mL of sterile 10% povidone-iodine (from a sterile catheter pack) with 1 L of 0.9% saline in a sterile splash basin. Solution will be left to soak for up to 3 minutes and remaining povidone-iodine solution will be suctioned away. Area will then be rinsed with 1L of n

Первичные конечные точки

  • Rate of acute (<90 days post-surgery) PJI [Срок оценки: 2 weeks after surgery, 3 months after surgery, within 90 day of surgery]
Вторичные конечные точки (6)
  • Rate of Superficial Wound Infections [Срок оценки: 2 weeks after surgery]
  • Rate of PJI at 1 year [Срок оценки: 12 months after surgery]
  • Subgroup analysis of PJI rates for high-risk patients [Срок оценки: 3 months after surgery, 12 months after surgery]
  • Patient Reported Functional Outcome Scores [Срок оценки: Before surgery, 3 months after surgery, 12 months after surgery]
  • Patient Reported Quality of Life Scores [Срок оценки: Before surgery, 3 months after surgery, 12 months after surgery]
  • Wound Complications (non-infection) requiring revision surgery [Срок оценки: 2 weeks after surgery]

Критерии участия

Критерии включения

  • Male and female patients aged 18 years or older
  • Diagnosis of osteoarthritis, inflammatory arthritis, osteonecrosis, or post-traumatic arthritis to the affected joint.
  • Primary TKA, THA, and HR
  • Subjects receiving both cemented or uncemented orthopaedic implants
  • Willing and able to sign written consent, follow study protocol and attend follow-up

Критерии исключения

  • Inability or refusal to sign informed consent form
  • Non-English or French speaking, and no licensed translator, family member or substitute decision maker available.
  • Prior arthroplasty procedure to the affected joint
  • Procedures involving solid HA implants
  • Oncologic diagnosis to the affected joint.
  • Non-TKA, THA or HR prosthesis (i.e., hemiarthroplasty, unicompartmental arthroplasty etc.)
  • Allergy to any of the components of XP Advanced Surgical Irrigation
  • Allergy to iodine
  • Presence of concurrent active infection, primary immunodeficiency, history of uncontrolled HIV (CD4 count <200 cells/uL), treatment with immunomodulatory medications for malignancy or autoimmune disease (with exception to inflammatory arthritis), chronic glucocorticosteroid use (≥20 mg of prednisone daily for at least 1 month with another cause of immunosuppression), and solid organ and/or bone marrow transplantation.
  • History of septic arthritis to the affected joint within two years of surgery(1).
  • History of steroid injection to the affected joint within the three months preceding surgery.
  • Simultaneous bilateral total joint arthroplasty

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Канада · 8 центров
  • University of British Columbia — Vancouver
  • London Health Sciences Center — London
  • The Ottawa Hospital — Ottawa
  • Humber River Health — Toronto
  • St. Joseph's Health Centre — Toronto
  • Hôpital Maisonneuve-Rosemont — Montreal
  • Jewish General Hospital — Montreal
  • CHU de Quebec-Université Laval — Québec

Идентификаторы

NCT: NCT05543941 · ISR-0104

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗