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Набор скоро начнётся NCT07070570

HAKA: Routine Follow-up at 10 Years After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?

Без фазы С лечением Hip Arthroplasty, Total Knee Arthroplasty, Total

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: Routine Follow-Up (RFU), Active Check-Up on Demand (ACOD), Passive Check-Up on Demand (PCOD).
Кому может быть актуально
Состояния в реестре: Hip Arthroplasty, Total, Knee Arthroplasty, Total. Базовые параметры: от 50 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
Нидерланды
Следующий шаг
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Обзор

After undergoing total hip or total knee arthroplasty, current guidelines recommend routine follow-up with an X-ray within 3 months and again at 1 year. Follow-up at 5 years (for hip arthroplasties) or every 5 years (for knee arthroplasties) is also considered worthwhile according to the guideline. However, these follow-up appointments require considerable time from patients, caregivers, and healthcare professionals, and it is unclear whether they are truly beneficial. It is possible that a single follow-up within 3 months is sufficient. This could potentially prevent over 100,000 unnecessary hospital visits per year, resulting in significant cost savings. If patients or healthcare providers have concerns, they can always request an additional follow-up. The HAKA trial consists of three different work packages (WPs). This trial (WP2) investigates the 10-year follow-up, WP1 examines the 1-year follow-up, and WP3 is a qualitative study exploring the experiences and perceptions of patients and healthcare professionals. The aim of the HAKA trial is to safely reduce routine follow-up appointments after total hip or knee arthroplasty and to revise current clinical guidelines accordingly.

Вмешательства

  • Другое Routine Follow-Up (RFU)
    Standard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery
  • Другое Active Check-Up on Demand (ACOD)
    X-ray, clinical visit and questionnaires at 10 years after surgery when requested by the patient or healthcare provider.
  • Другое Passive Check-Up on Demand (PCOD)
    X-ray and clinical visit (without questionnaires) at 10 year when requested by the patient or healthcare provider.

Первичные конечные точки

  • Number of complications [Срок оценки: Assessed until 11 years after implantation]
  • Type of complications [Срок оценки: Assessed until 11 years after implantation]
  • Healthcare consumption [Срок оценки: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.]
Вторичные конечные точки (9)
  • PROMIS Physical Function [Срок оценки: Assessed at 10 and 11 years after implantation]
  • Number of surgical interventions [Срок оценки: Assessed until 11 years after implantation]
  • Type of Surgical Interventions [Срок оценки: Assessed until 11 years after implantation]
  • Number of additional healthcare consumption [Срок оценки: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.]
  • Type of additional healthcare consumption [Срок оценки: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.]
  • Costs related to THA or TKA follow-up [Срок оценки: Assessed at 10 years after implantation and then after at 3 months, 6 months and 12 months.]
  • Numeric Pain Rating Scale (NPRS) [Срок оценки: Assessed at 10 and 11 years after implantation]
  • Numeric Satisfaction Rating Scale (NSRS) [Срок оценки: Assessed at 10 and 11 years after implantation]
  • Health related quality of life (EQ-5D-5L) [Срок оценки: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months]

Критерии участия

Критерии включения

  • Underwent primary THA or TKA approximately 10 years ago
  • Age 50 years or older at time of THA or TKA
  • Capable and willing to complete questionnaires (when applicable)
  • Understanding Dutch or English
  • Willing to provide written informed consent in case the patient will complete questionnaires

Критерии исключения

  • Other indication for surgery than osteoarthritis
  • Deceased
  • Revision arthroplasty of hip or knee, except a conversion from unicompartmental knee arthroplasty to TKA or from hip hemiarthroplasty/resurfacing to THA
  • Already participating in this study due to another hip or knee surgery

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
Открытое
Основная цель
Диагностика

Центры проведения

Нидерланды · 1 центр
  • Reinier Haga Orthopedisch Centrum — Zoetermeer

Идентификаторы

NCT: NCT07070570 · OC-2024-011

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗