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Идёт набор NCT06971757

HAKA: Routine Follow-Up at 1 Year 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), Check-Up on Demand (COD).
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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Cost-effectiveness of Routine Follow-up at One Year After Total Hip and Knee Arthroplasty Compared to Check-up on Demand: a Multicenter Hybrid Stepped-wedge Cluster De-implementation Study

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 (WP1) investigates the 1-year follow-up, WP2 examines the 10-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 and clinical visit at 3 months and 1 year after surgery.
  • Другое Check-Up on Demand (COD)
    Follow-up care with scheduled X-ray and clinical visit at 3 months and only at 1 year if requested.

Первичные конечные точки

  • PROMIS Physical Function [Срок оценки: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.]
  • Number of clinical visits and X-rays [Срок оценки: From surgery until 24 months after surgery.]
Вторичные конечные точки (7)
  • Number of complications [Срок оценки: From surgery until 24 months after surgery.]
  • Type of Complications [Срок оценки: From surgery until 24 months after surgery.]
  • Number of surgical interventions [Срок оценки: From surgery until 24 months after surgery.]
  • Type of Surgical Interventions [Срок оценки: From surgery until 24 months after surgery]
  • Costs related to THA or TKA follow-up [Срок оценки: Assessed at 15, 18, and 24 months after surgery.]
  • Numeric Pain Rating Scale (NPRS) [Срок оценки: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.]
  • EQ-5D-5L [Срок оценки: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.]

Критерии участия

Критерии включения

  • Painful and disabled hip or knee joint resulting from osteoarthritis
  • Scheduled for primary THA or TKA surgery
  • Age 50 years or older at the time of THA or TKA
  • Capable and willing to complete questionnaires
  • Proficient in Dutch or English
  • Willing to provide informed consent

Критерии исключения

  • Other indication for surgery than osteoarthritis
  • Scheduled for hip or knee revision arthroplasty, except a conversion from unicompartmental knee arthroplasty to TKA or from hip hemiarthroplasty/resurfacing to THA
  • Already participating in this study due to a previous 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 · 9 центров
  • OLVG — Amsterdam
  • Amphia — Breda
  • Deventer Ziekenhuis — Deventer
  • Admiraal de Ruyter Ziekenhuis — Goes
  • Martini Ziekenhuis — Groningen
  • Tergooi MC — Hilversum
  • Canisius Wilhelmina Ziekenhuis — Nijmegen
  • ZorgSaam Zeeuws Vlaanderen — Terneuzen
  • … и ещё 1 центр

Публикации

  • Rasker AJ, Roubos LAC, Baas DC, Verhagen RAW, de Jong LD, Rutgers M, Vorrink SNW, Pasma JH, Poolman RW, Willigenburg NW. Is check-up on demand non-inferior to routine follow-up at one year after total hip or knee arthroplasty in terms of clinical outcomes and cost-effectiveness? Protocol for a randomized stepped-wedge hybrid effectiveness de-implementation trial. PLoS One. 2026 Mar 17;21(3):e03436 PMID 41843589

Идентификаторы

NCT: NCT06971757 · NL-009246 · 10330042310003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗