Идёт набор NCT03869996

Total Knee Arthroplasty: Fast Track Protocol is the Future?

Без фазы С лечением Osteoarthritis, Knee Arthropathy of Knee

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: fast track care protocol, standard care protocol.
Кому может быть актуально: Состояния в реестре: Osteoarthritis, Knee, Arthropathy of Knee. Базовые параметры: 18 лет — 78 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

Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on the Functional Outcomes and Hospital Stay of Total Knee Arthroplasty

Обзор

Fast-track total knee arthroplasty (TKA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. The aim of this protocol is to compare the standard care and fast track total knee arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.

Подробное описание

The aim of this protocol is to compare standard care and fast track total knee arthroplasties. The fast track care consists of:

* preoperative educational lesson in which orthopedic surgeon, anesthesiologist and physiotherapist illustrate the operative and post operative path to the patients * antalgic protocol administered only orally * early rehabilitation care. The day of the surgical operation, the physiotherapist helps the patient reach the upright position.

The standard care consists of usual antalgic and physiotherapy post-operative care:

* Antalgic protocol consist in intravenous drugs * the first physiotherapy session is the day after surgery.

Вмешательства

Процедура fast track care protocol
fast track care consists in educational preoperative preparation for patients, particular strategies for controlling pain and bleeding and intensive early rehabilitation protocol.
Процедура standard care protocol
standard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.

Первичные конечные точки

Early functional outcomes [Срок оценки: Third post operative day]

Вторичные конечные точки (12)

hospital staying [Срок оценки: Third day after surgery]
Incidence of early major complications [Срок оценки: Third day after surgery]
Number of transfusions [Срок оценки: Third day after surgery]
Analgesic consumption [Срок оценки: Third day after surgery]
Knee Society Score (KSS) at 6 weeks [Срок оценки: 6 weeks after surgery]
Knee Society Score (KSS) at third month [Срок оценки: third month after surgery]
Knee Society Score (KSS) at sixth month [Срок оценки: sixth month after surgery]
Knee Society Score (KSS) at twelfth month [Срок оценки: twelfth month after surgery]
Oxford Score (OS) at 6 weeks [Срок оценки: 6 weeks after surgery]
Oxford Score (OS) at third month [Срок оценки: third month after surgery]
Oxford Score (OS) at sixth month [Срок оценки: sixth month after surgery]
Oxford Score (OS) at twelfth month [Срок оценки: twelfth month after surgery]

Критерии участия

Критерии включения

patients affected by knee osteoarthritis, eligible for primary total knee arthroplasty
BMI < 32
Time up ang go test </= 12 seconds
American Society of Anesthesiologists physical status classification system (ASA) </= 2
preoperative hemoglobin (HB) >13 g/dl
patients eligible for spinal anesthesia
presence of a care-giver