A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation
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: Dexamethasone Sodium Phosphate 4 mg/ml intravenous, Dexamethasone Sodium Phosphate 4 mg/ml intra-articular.
- Кому может быть актуально
- Состояния в реестре: Total Knee Replacement. Базовые параметры: 50 лет — 85 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
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Comparison of Perioperative Intravenous vs Periarticular Dexamethasone vs no Steroid Supplementation in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Primary Total Knee Arthroplasty for Knee Osteoarthritis - A Randomized Controlled Trial Clinical Study Protocol
Обзор
We are going to evaluate the difference between perioperative intravenous steroid supplementation, perioperative periarticular steroid supplementation, and standard anaesthesia protocols. We'll evaluate the outcome of patients with knee osteoarthritis who are undergoing Total Knee Arthroplasty to understand which of the three treatments give more benefits to the patient.
Подробное описание
A total of 159 patients will be needed (53 patients per arm, 3 arms in total). Dexamethasone (brand name: Mephameson) is the steroid drug that we perioperative administer in two different ways: intra-venous (IV) dexamethasone (9mg) in arm-A, intra-articular (IA) dexamethasone (9mg) in arm-B. No steroid supplementation will be provided in the control group (arm-C).
The primary objective of the study is to compare the effect on post-operative pain of I.V. and I.A. perioperative dexamethasone supplementation for total knee arthroplasty (TKA).
The secondary objectives of the studies will be the comparison between I.V. and I.A. peri-operative dexamethasone supplementation in terms of post-operative pain and function, opioids and analgesic drugs consumption, knee range of motion, systemic inflammatory response, time to mobilisation, length of stay, and patient satisfaction.
Moreover, both I.V. and I.A. steroid supplementation protocols will be compared to routine analgesia protocol (no steroid supplementation group) in order to document their advantages over the absence of steroid supplementation.
The safety of I.V. and I.A. peri-operative dexamethasone will be evaluated and compared recording all the steroid supplementation related complications. In particular, the risk of hyperglycaemia-related complications and post-operative infections will be documented. The safety of both I.V. and I.A. steroid supplementation protocols will be verified comparing them to the no-treatment group in terms of incidence of complications.
Overall study duration will be 12 years: 2 years to enroll all the patients and 10 years to complete the last follow-up. Primary data analysis is planned after the completion of the 1-year follow-up visits.
Вмешательства
- Препарат Dexamethasone Sodium Phosphate 4 mg/ml intravenous
Perioperative intravenous injection of 3 ml of solution (9mg of dexamethasone) - Препарат Dexamethasone Sodium Phosphate 4 mg/ml intra-articular
Perioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)
Первичные конечные точки
- Mean daily pain at rest during the first 3 days on a 0-10 numeric rating scale [Срок оценки: 3 days after surgery]
Вторичные конечные точки (12)
- Post-operative knee pain during the first 6 weeks after surgery on a 0-10 numeric rating scale [Срок оценки: 6 weeks after surgery]
- Post-operative knee pain during the first 10 years after surgery [Срок оценки: 10 years]
- Post-operative function during the first 6 weeks after surgery [Срок оценки: 6 weeks]
- Post-operative knee function during the first 10 years after surgery [Срок оценки: 10 years]
- Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index (WOMAC) [Срок оценки: 10 years]
- Knee conditions on Knee society score (KSS) [Срок оценки: 10 years]
- Quality of pain on PainDETECT questionnaire [Срок оценки: 10 years]
- Patient satisfaction: numeric rating scale (NRS) [Срок оценки: 10 years]
- Post-operative nausea incidence [Срок оценки: During Hospitalization, approximately 3 days]
- Post-operative nausea intensity [Срок оценки: During Hospitalization, approximately 3 days]
- Post-operative opioids and analgesic drugs consumption [Срок оценки: During Hospitalization, approximately 3 days]
- Post-operative C-Reactive Protein (CRP) [Срок оценки: every days 3 days from surgery]
Критерии участия
Критерии включения
- Patients undergoing unilateral primary TKA at the Ospedale Regionale di Lugano.
- Patients with a BMI >18.5 and <35.
- Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
- Informed Consent as documented by signature (Appendix Informed Consent Form).
Критерии исключения
- Contraindications to steroids.
- Revision TKA.
- Active steroid therapy.
- Women who are pregnant or breast feeding.
- Presence of other clinically significant concomitant disease states (ASA IV).
- Uncontrolled diabetes mellitus
- Known or suspected non-compliance, drug or alcohol abuse.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
- Previous enrolment into the current study.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Швейцария · 1 центр
- Ospedale Regionale di Lugano Civico e Italiano — Lugano
Идентификаторы
NCT: NCT04432012 · ORL-ORT-013