Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome
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: Cryopressotherapy, Ice pack.
- Кому может быть актуально
- Состояния в реестре: Total Knee Arthroplasty\(TKA\), Osteoartrosi. Базовые параметры: 18 лет — 80 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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Обзор
The purpose of this study is to evaluate the effectiveness of cryopressotherapy in patients undergoing total knee arthroplasty by assessing clinical improvement using the KOOS at 14 days after surgery. Analysis of the knee Range of Motion (ROM) in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery. Analysis of PROMs such as: Oxford Knee Score (OKS), Joint Forgotten (JF), NRS score, and SF-12. These questionnaires will be collected in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery. To evaluate whether cryopressotherapy leads to an improvement in predischarge hemoglobin (Hb) levels. To assess whether cryopressotherapy reduces the circumference and subcutaneous fluid accumulation of the operated limb.
Подробное описание
Knee osteoarthritis is a degenerative condition that causes cartilage wear, leading to pain, stiffness, and difficulty moving. It mainly affects older adults, but it can also occur in younger individuals in cases of genetic predisposition or trauma. Symptoms include pain during or after physical activity, swelling, and difficulty walking.
Initial treatment is based on physiotherapy, anti-inflammatory medications, and injections, but if the disease progresses, a total knee replacement with a prosthesis may become necessary. Modern prostheses are made with advanced materials and minimally invasive surgical techniques, improving postoperative recovery.
Using ice in the first few days after surgery is crucial to reducing pain and swelling, improving functional recovery, and lowering the need for pain medications, such as opioids. Moreover, ice therapy promotes early rehabilitation and reduces hospitalization time. Cryotherapy may also help lower healthcare costs thanks to more effective pain management.
Advanced continuous cooling devices, although promising, require further studies to confirm their effectiveness.
The aim of the study is therefore to assess whether the cryopressotherapy protocol leads to an improvement in clinical outcomes in patients undergoing total knee arthroplasty (TKA), earlier mobilization, and reduced use of pain medication.
Вмешательства
- Устройство Cryopressotherapy
Comparison between Cryopressotherapy and ice pack in patients undergoing Total Knee Arthroplasty to improve clinical outcomes - Устройство Ice pack
Comparison between ice pack and cryopressotherapy
Первичные конечные точки
- Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 14 Days Postoperatively [Срок оценки: Preoperative assessment and 14 days postoperatively.]
Вторичные конечные точки (7)
- Analysis of the knee Range of Motion (ROM) in the preoperative phase [Срок оценки: Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit).]
- Analysis of PROMs (Patient-Reported Outcome Measures): Oxford Knee Score (OKS) [Срок оценки: Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit).]
- Analysis of PROMs (Patient-Reported Outcome Measures): Forgotten Joint Score (FJS-12) [Срок оценки: Pre-discharge visit; 14 days postoperatively (suture removal visit).]
- Analysis of PROMs (Patient-Reported Outcome Measures): Numerical Rating Scale (NRS) for pain [Срок оценки: Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit)]
- Analysis of PROMs (Patient-Reported Outcome Measures): Short Form-12 Health Survey (SF-12) [Срок оценки: Preoperative assessment; pre-discharge visit; 14 days postoperatively (suture removal visit)]
- Improvement in hemoglobin (Hb) levels [Срок оценки: Preoperative assessment and pre-discharge visit]
- Change in operated limb circumference [Срок оценки: Preoperative assessment; pre-discharge visit; 14 days postoperatively.]
Критерии участия
Критерии включения
- Candidates for elective total knee arthroplasty surgery (indication determined solely by the Orthopedic Surgeon)
- Patients aged between 18 and 80 years (inclusive) for both groups
- Body Mass Index (BMI) between 18 and 35 kg/m²
- Willingness and ability to provide informed consent
- Patients with non-inflammatory degenerative knee joint disease, including osteoarthritis
Критерии исключения
- Use of medications that may interfere with muscle metabolism
- Bone metastases or diseases at the surgical site
- Presence or suspicion of infection at the knee
- Inability to provide informed consent
- Obesity (BMI ≥ 35 kg/m²)
- Patients requiring revision surgery of total knee arthroplasty
- Patients with pacemakers and/or mechanical implants or those who may be affected by BIA interference
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
- Поддерживающая терапия
Центры проведения
Италия · 1 центр
- IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Milan 20173 — Milan
Идентификаторы
NCT: NCT07456787 · CRYO-KNEE