Frailty in Hip or Knee Arthroplasty Patients.
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: Frail Elderly, Arthroplasties Hip Replacement, Arthroplasty Knee. 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
- Италия
- 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
The Role of Frailty in the Rehabilitation Pathway Following Hip or Knee Arthroplasty Surgery.
Обзор
The study aims to understand the existing differences between frail and non-frail subjects who underwent a rehabilitation path after receiving hip or knee arthroplasty surgery.
Подробное описание
This study wanted to investigate the role of frailty in the rehabilitation path following hip or knee arthroplasty. Subjects will be divided according to the type of arthroplasty received (i.e., hip or knee arthroplasty). Consequently, each arthroplasty group will be divided into a frail group and a non-frail group based on the presence of frailty conditions before receiving surgery. Frailty condition will be assessed using the Primary Care Frailty Index, based on the information reported in each patient's medical record before surgery. Frailty level will be reassessed during the rehabilitation period, specifically at hospitalization in the rehabilitation ward (T0) and Discharge (T1). While other time points considered for the primary outcomes will be at 3-month follow-up (T2) and 1-year follow-up (T3), alongside the primary and secondary outcomes chosen for the study. The different outcomes considered in this study were selected to provide a wide range of information regarding body structure and function, activity level, and perceived level of satisfaction with the intervention. Moreover, the long-term follow-up will collect data on the adverse event rate, which previous studies have shown to significantly impact more frail subjects after receiving arthroplasty. However, the possible protective role of rehabilitation has never been considered. This prospective case-control study is the first to consider the crucial role of rehabilitation in the post-surgical path of subjects receiving arthroplasties. It can serve as a preliminary basis for further trials based on tailored interventions for frail subjects.
Первичные конечные точки
- Oxford Hip Score [Срок оценки: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).]
- Oxford Knee Score [Срок оценки: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).]
Вторичные конечные точки (5)
- modified Barthel Index [Срок оценки: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).]
- Numerical Pain Raitng Scale [Срок оценки: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).]
- Adverse events [Срок оценки: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).]
- International Knee Society Rating System [Срок оценки: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).]
- Merlè D'Aubigne-Postel Scale [Срок оценки: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).]
Критерии участия
Критерии включения
- Received elective hip or knee arthroplasty;
- Ability to understand written and oral instructions;
- Gave consent to study participation.
Критерии исключения
- Arthroplasty revision or not elective intervention;
- Participation in other studies;
- Hospitalized in the rehabilitation ward more then 10 days after surgery.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Италия · 1 центр
- Centro "E. Spalenza - Don Gnocchi — Rovato
Идентификаторы
NCT: NCT07086716 · JP-004