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Идёт набор NCT06088160

Changes in Postural Stability Following THA for OA

— Наблюдательное Osteoarthritis, Hip

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: Total Hip Arthroplasty.
Кому может быть актуально
Состояния в реестре: Osteoarthritis, Hip. Базовые параметры: от 60 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
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Официальное название

Changes in Postural Stability and Balance Confidence in People After Elective Unilateral Total Hip Arthroplasty for Osteoarthritis: A Prospective Cohort Study

Обзор

Total hip arthroplasty (THA) is a common surgery that eases pain, restores functional movement, and improves the overall quality of life in people with severe hip osteoarthritis (OA). Unfortunately, problems with postural stability, commonly known as balance, are still noticed in people even years after the surgery. These postural stability problems typically result in falls. The aim of the proposed study is to investigate how THA surgery affects a person's overall quality of life, both physically and psychologically, in terms of postural stability and balance confidence (self-efficacy) within the first three months after THA for osteoarthritis. This prospective cohort study will focus on people over 60 years old.

Подробное описание

The purpose of this study is to evaluate the changes in postural stability and balance confidence during the initial three months after elective unilateral total hip arthroplasty for osteoarthritis. Specifically, the investigators aim to:

1. To evaluate change in postural stability between the DA and DL surgical approaches during the first three months after elective unilateral THA for OA, using both a clinical measure and an instrumented measure. 2. To evaluate change in balance confidence between the DA and DL surgical approaches during the first three months after elective unilateral THA for OA.

Secondary objective 3. To compare the DA and DL approaches for activity levels, function, quality of life and pain during the first three months after elective unilateral THA for OA.

Вмешательства

  • Процедура Total Hip Arthroplasty
    Total hip arthroplasty is a common surgical procedure performed in people with advanced hip osteoarthritis

Первичные конечные точки

  • The Balance Evaluation Systems Test (BESTest) [Срок оценки: Pre-THA, and at 2, 6, and 12 weeks post-THA]
  • The Activities-specific Balance Confidence (ABC) scale [Срок оценки: Pre-THA, and at 2, 6, and 12 weeks post-THA]
Вторичные конечные точки (6)
  • The University of California, Los Angeles (UCLA) activity scale [Срок оценки: Pre-THA, and at 2, 6, and 12 weeks post-THA]
  • The EuroQol-Five Dimensions-Five Levels (EQ-5D-5L) [Срок оценки: Pre-THA, and at 2, 6, and 12 weeks post-THA]
  • The Harris Hip Score [Срок оценки: Pre-THA, and at 2, 6, and 12 weeks post-THA]
  • The Western Ontario and McMaster Osteoarthritis Index (WOMAC) questionnaire [Срок оценки: Pre-THA, and at 2, 6, and 12 weeks post-THA]
  • Preoperative Fall Assessment: History of falls (previous 12 months), circumstances of falls, and injury (major or minor). [Срок оценки: Pre-THA]
  • Postoperative Fall Assessment: Prospective (daily) number of falls for 12 weeks post-THA, circumstances of falls, and injury (major or minor). [Срок оценки: 2, 6, and 12 weeks post-THA]

Критерии участия

Критерии включения

  • ≥ 60 years of age, scheduled to receive an elective unilateral THA (DA or DL approach) for OA
  • Ambulatory for a minimum of 10 meters with or without a mobility aid but without the assistance of another person
  • Able to read, write and speak English
  • Able to provide consent

Критерии исключения

  • Bilateral THA
  • Underwent THA surgery for a diagnosis other than OA
  • Any condition that will prevent participants from completing the study such as having a significant neurological, cardiovascular, musculoskeletal condition as denoted by their physician.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • London Health Sciences Centre- University Hospital — London

Идентификаторы

NCT: NCT06088160 · 123634

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗