Меню
Набор скоро начнётся NCT07506434

Tourniquet Vs. No-Tourniquet Technique in Total Knee Arthroplasty at the University Hospital of the West Indies

Без фазы С лечением Knee Osteoarthritis (OA) Total Knee Anthroplasty

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: pneumatic tourniquet.
Кому может быть актуально
Состояния в реестре: Knee Osteoarthritis (OA), Total Knee Anthroplasty. 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
Jamaica
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

Is Routine Tourniquet Use Still Warranted? A Randomized Controlled Equivalence Trial Comparing Tourniquet Vs. No-Tourniquet Technique in Total Knee Arthroplasty at the University Hospital of the West Indies

Обзор

The goal of this clinical trial is to determine whether performing total knee replacement surgery (total knee arthroplasty, TKA) without a tourniquet is clinically equivalent to performing the procedure with a tourniquet in adults with symptomatic knee osteoarthritis. A tourniquet is commonly used during surgery to reduce bleeding and improve the surgeon's view. However, some studies suggest it may be associated with certain complications. It is currently unclear whether using a tourniquet meaningfully changes outcomes compared to not using one. This study aims to assess whether both approaches result in similar outcomes within a clinically acceptable range. The main question this study aims to answer is: Is total blood loss during surgery equivalent between TKA performed with a tourniquet and TKA performed without a tourniquet, within a predefined margin of ±100 mL? Additional questions include: Are surgical field quality, postoperative pain, functional recovery, and complication rates comparable between the two techniques? Researchers will compare: TKA performed with a pneumatic tourniquet TKA performed without a tourniquet to determine whether outcomes between the two approaches are equivalent rather than whether one is superior to the other. Participants will: Be randomly assigned to one of the two surgical groups using a computer-generated process Undergo standard total knee replacement surgery and routine perioperative care Have blood loss assessed during and after surgery Be monitored for pain, recovery of function, wound healing, and complications during hospital stay and follow-up visits This study is designed as a randomized controlled equivalence trial to determine whether both surgical approaches produce comparable outcomes within clinically acceptable limits, in a standardized local setting.

Вмешательства

  • Устройство pneumatic tourniquet
    the use of a pneumatic tourniquet throughout the entire total knee replacement procedure

Первичные конечные точки

  • Total perioperative blood loss [Срок оценки: Hb values (pre- and postoperative day 3) will be measured]
Вторичные конечные точки (5)
  • Bone-cement interface quality [Срок оценки: Taken Intraoperatively]
  • Postoperative pain [Срок оценки: Patients will be asked to mark their pain level at 24 and 48 hours postoperatively.]
  • Knee range of motion [Срок оценки: Measured at postoperative day 2 and 6 weeks by a physiotherapist blinded to group allocation.]
  • Knee Injury and Osteoarthritis Outcomes Score for Joint Replacement (KOOS JR) Survey score [Срок оценки: Administered at postoperative day 2 and 6 weeks by the research coordinator.]
  • Perioperative complications [Срок оценки: Recorded up to 6 weeks postoperatively]

Критерии участия

Критерии включения

  • • Age ≥ 18 years.
  • Clinical and radiographic diagnosis of knee osteoarthritis requiring primary unilateral Total Knee Arthroplasty.
  • Medically fit for elective surgery (typically ASA I-III).
  • Able to provide informed consent.

Критерии исключения

  • • Revision TKA or bilateral simultaneous TKA.
  • Preexisting coagulopathy or active anticoagulation that cannot be perioperatively managed per protocol.
  • Known allergy or contraindication to tranexamic acid.
  • Active infection or immunosuppression.
  • Severe peripheral vascular disease in the operative limb.
  • BMI > 45 kg/m²
  • Inability to provide informed consent or comply with follow-up

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

Jamaica · 1 центр
  • University Hospital of the West Indies — Kingston

Идентификаторы

NCT: NCT07506434 · CREC-MN.065,2025/2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗