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Набор скоро начнётся NCT07041528

Perceptions of De-implementing Routine Follow-ups After Hip and Knee Arthroplasty

— Наблюдательное 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
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

How Do Patients and Health Care Professionals Perceive De-implementation of Routine Follow-ups After Total Hip and Knee Arthroplasty? Protocol for a Nested Qualitative Study Within a Hybrid De-implementation Trial

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 guidelines. 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).The quantitative work packages 1 (WP1) and 2 (WP2) will investigate the 1-year and 10-year follow-up. The qualitative third work package (WP3) will explore and compare the patients' and health care professionals' (HCPs) experiences with, and perceptions about, RFU and COD after total hip and knee arthroplasty. The aim of the overarching HAKA-trial is to safely reduce routine follow-up appointments after total hip or knee arthroplasty and to revise current clinical guidelines accordingly.

Первичные конечные точки

  • The participants' experiences with their follow-up regimen. [Срок оценки: Experiences gained between the baseline clinical visit and a clinical visit one year later.]
  • The participants' satisfaction with their follow-up regimen. [Срок оценки: Perceived satisfaction between the baseline clinical visit and a clinical visit one year later.]
  • The health care professionals' experiences with the different follow-up regimens. [Срок оценки: Experiences gained between the baseline clinical visit and a clinical visit one year later.]
  • The health care professionals' satisfaction with the different follow-up regimens. [Срок оценки: Perceived satisfaction between the baseline clinical visit and a clinical visit one year later.]
  • The participants' and health care professionals' acceptability of the two different follow-up regimens. [Срок оценки: Acceptability of follow-up regimens from the baseline clinical visit to a clinical visit one year later.]

Критерии участия

Критерии включения

  • A good command of the Dutch language

Критерии исключения

  • N/A

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Нидерланды · 1 центр
  • Tergooi MC — Hilversum

Публикации

  • Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7. PMID 17964352
  • Price AJ, Alvand A, Troelsen A, Katz JN, Hooper G, Gray A, Carr A, Beard D. Knee replacement. Lancet. 2018 Nov 3;392(10158):1672-1682. doi: 10.1016/S0140-6736(18)32344-4. PMID 30496082
  • Christensen M, Folkmar K. No clinical value of post-operative routine X-ray following uncomplicated cementless primary total hip arthroplasty. Dan Med J. 2013 Apr;60(4):A4613. PMID 23651720
  • Hart AA, DeMik DE, Brown TS, Noiseux NO. Routine Radiographs After Total Joint Arthroplasty: Is There Clinical Value? J Arthroplasty. 2021 Jul;36(7):2431-2434. doi: 10.1016/j.arth.2021.02.050. Epub 2021 Feb 24. PMID 33714635
  • Dargel J, Oppermann J, Bruggemann GP, Eysel P. Dislocation following total hip replacement. Dtsch Arztebl Int. 2014 Dec 22;111(51-52):884-90. doi: 10.3238/arztebl.2014.0884. PMID 25597367
  • Blom AW, Beswick AD, Burston A, Carroll FE, Garfield K, Gooberman-Hill R, Harris S, Kunutsor SK, Lane A, Lenguerrand E, MacGowan A, Mallon C, Moore AJ, Noble S, Palmer CK, Rolfson O, Strange S, Whitehouse MR. Infection after total joint replacement of the hip and knee: research programme including the INFORM RCT [Internet]. Southampton (UK): National Institute for Health and Care Research; 2022 No PMID 36469653
  • Lindeque B, Hartman Z, Noshchenko A, Cruse M. Infection after primary total hip arthroplasty. Orthopedics. 2014 Apr;37(4):257-65. doi: 10.3928/01477447-20140401-08. PMID 24762833
  • Schwartz AM, Farley KX, Guild GN, Bradbury TL Jr. Projections and Epidemiology of Revision Hip and Knee Arthroplasty in the United States to 2030. J Arthroplasty. 2020 Jun;35(6S):S79-S85. doi: 10.1016/j.arth.2020.02.030. Epub 2020 Feb 19. PMID 32151524

Идентификаторы

NCT: NCT07041528 · N25.014 · 10330042310003

Первоисточники (государственные реестры)

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