Is Non Surgical CaRE Using Treat to Target Multimodal meDIcal Strategies aBLE to Delay or Avoid Total Knee Replacement?
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: arthroplasty, Medical and non-medical treatments.
- Кому может быть актуально
- Состояния в реестре: Osteoarthritis, Knee. Базовые параметры: 18 лет — 90 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
- Франция
- 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
Is Non Surgical CaRE Using Treat to Target Multimodal meDIcal Strategies aBLE to Delay or Avoid Total Knee Replacement? (INCREDIBLE)
Обзор
Knee is the most common site of osteoarthritis. Treatment of knee osteoarthritis starts with a full course of medical therapy, followed by surgery to replace the knee with a prosthesis if this strategy fails, or in advanced cases. However, the new recommendations of the French rheumatology society, which evaluate the various treatments and position them in the treatment plan, are not well known, and the definition of a complete treatment remains unclear. The vast majority of patients are therefore referred to a surgeon after having tried a small part of the therapeutic arsenal (generally analgesics and corticosteroid or hyaluronic acid infiltrations). The goal of this study is to to select patients most likely to gain from surgery and to develop strategies that avoid the need for major surgery.
Подробное описание
Knee is the most common site of osteoarthritis. Treatment of knee osteoarthritis starts with a full course of medical therapy, followed by surgery to replace the knee with a prosthesis if this strategy fails, or in advanced cases.
However, the new recommendations of the French rheumatology society, which evaluate the various treatments and position them in the treatment plan, are not well known, and the definition of a complete treatment remains unclear. The vast majority of patients are therefore referred to a surgeon after having tried a small part of the therapeutic arsenal (generally analgesics and corticosteroid or hyaluronic acid infiltrations).
Yet medical treatment has proved effective, suggesting that it could prevent a significant number of total knee arthroplasties. In addition, osteoarthritis of the knee is associated with various co-morbidities (diabetes, cardiovascular) that medical treatment can minimize (diet, physical activity).
The effectiveness of knee prostheses has been demonstrated, but up to 20% of patients continue to experience pain, and surgical procedures induce rare but serious events. Prostheses can also be revised, and are expensive.
This research is designed for patients suffering from femoro-tibial osteoarthritis who have been proposed total knee replacement by a surgeon, and aims to develop strategies to avoid the need for major surgery until the medical treatment arsenal adapted to the patient's situation has been tried.
In the treatment of osteoarthritis, the impact of shared decision-making between rheumatologists, orthopaedic surgeons and the patient in the event of incomplete medical treatment has been shown to be important, as the decision is often modified after discussion.
The main objective of this prospective, randomized, pragmatic, non-blinded, multicenter study is to investigate whether shared decision-making coupled with multimodal medical strategies delays surgery by at least 2 years in most patients, with non-inferiority on pain and function, lower cost and fewer serious adverse events compared with total knee arthroplasty from the outset.
Вмешательства
- Процедура arthroplasty
In the surgery arm, patients will have their surgery (arthroplasty), as originally planned. - Другое Medical and non-medical treatments
In the medical care arm, patients will follow multimodal medical strategies to prevent surgery in a population of patients with knee osteoarthritis having a first indication of knee prosthesis
Первичные конечные точки
- Multimodal medical care osteoarthritis is non inferior (with a threshold of 15% for pain and function) to total knee arthroplasty in symptomatic radiographic knee osteoarthritis. [Срок оценки: 2 years]
Вторичные конечные точки (6)
- Study the proportion of delayed surgery in the medical group [Срок оценки: 2 years]
- Study the proportion of patients with severe events induced by surgery [Срок оценки: 2 years]
- Analyze the impact of physical activity on change of body mass by arm in the randomized population. [Срок оценки: 2 years]
- To compare analgesic use by arm. [Срок оценки: 2 years]
- To compare the 0-2 years cost using the National Health Data System between the 2 groups. [Срок оценки: 0-2 years]
- To compare the 2-5 cost using the National Health Data System between the 2 groups. [Срок оценки: 2-5 years]
Критерии участия
Критерии включения
- Age 18-90 years old
- Femoro-tibial osteoarthritis Kellgren stage stage≥ 2 without laxity in extension;
- A proposal of total knee replacement by a surgeon;
- No corticosteroid joint injection within 3 months;
- Visual analogic score pain (VAS) >40/100 but <90/100 or Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index function sub scale >40/100 at inclusion;
- Wish to discuss medical care;
- Able to consent and having signed a consent form.
Критерии исключения
- Contraindication or no indication to surgery or medical care (severe infection for example)
- Inflammatory arthritis
- Lack of social insurance
- Symptomatic (VAS pain >40) contralateral knee or hip osteoarthritis (with or without replacement)
- Pregnant or breastfeeding woman
- Patient under court protection, guardianship, curatorship
- Patient deprived of liberty
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
- Лечение
Центры проведения
Франция · 21 центр
- CHU Amiens — Amiens
- CHU Brest — Brest
- CHU Caen — Caen
- CHD Vendée — La Roche-sur-Yon
- CHU Le Mans — Le Mans
- CHU Limoges — Limoges
- GHICL- Hôpital Saint Philibert — Lomme
- HCL — Lyon
- … и ещё 13 центров
Идентификаторы
NCT: NCT06643845 · 29BRC23.0002