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Идёт набор NCT06010979

Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology

— Наблюдательное Knee Osteoarthritis

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: conventional intrumentation assisted knee arthroplasty, computer navigation assisted knee arthroplasty, robotic system assisted knee arthroplasty, patient-spercific assisted knee arthroplasty.
Кому может быть актуально
Состояния в реестре: Knee Osteoarthritis. Базовые параметры: Без ограничений · 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Through this cohort study, previous clinical data can be systematically reviewed and supplemented through clinical follow-up. Prospective enrollment and follow-up observation of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The intraoperative, perioperative, clinical follow-up and health economics of surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA were comprehensively and objectively compared, the results and conclusions of the center were summarized and reported, and the effectiveness and safety of digital assistive technology applied to TKA were explored, providing references for clinical diagnosis and follow-up research.

Подробное описание

Through this cohort study, previous clinical data can be systematically reviewed and supplemented by follow-up visits. Prospective enrollment and follow-up of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The preoperative situation (general statistical information, educational level, preoperative clinical function score, etc.), intraoperative situation (operative time, intraoperative blood loss, intraoperative complications, etc.), perioperative situation (total postoperative blood loss, blood transfusion rate, postoperative complications, etc.) and clinical follow-up situation were comprehensively and objectively compared with surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA We summarized and reported the results and conclusions of the center (postoperative force line, implant location, pain, mobility, clinical function score, patient satisfaction and postoperative complications, etc.) and health economics (average length of stay, hospitalization cost, etc.) to provide reference for clinical diagnosis and follow-up research.

Вмешательства

  • Процедура conventional intrumentation assisted knee arthroplasty
    conventional intrumentation assisted knee arthroplasty
  • Процедура computer navigation assisted knee arthroplasty
    computer navigation assisted knee arthroplasty
  • Процедура robotic system assisted knee arthroplasty
    robotic system assisted knee arthroplasty
  • Процедура patient-spercific assisted knee arthroplasty
    patient-spercific assisted knee arthroplasty

Первичные конечные точки

  • mechanical axis [Срок оценки: Postoperative day 3]
Вторичные конечные точки (12)
  • operation time [Срок оценки: immediately after the surgery]
  • Intraoperative blood loss [Срок оценки: immediately after the surgery]
  • Intraoperative complications [Срок оценки: immediately after the surgery]
  • Total postoperative blood loss [Срок оценки: Postoperative day 3]
  • Blood transfusion rate [Срок оценки: At discharge]
  • Postoperative complication [Срок оценки: 3 years postoperatively]
  • Rotation Angle of femur prosthesis [Срок оценки: Postoperative day 3]
  • Visual analogue scale [Срок оценки: Postoperative day 3]
  • Visual analogue scale [Срок оценки: 2 weeks postoperatively]
  • Visual analogue scale [Срок оценки: 6 weeks postoperatively]
  • Visual analogue scale [Срок оценки: 3 months postoperatively]
  • Visual analogue scale [Срок оценки: 6 months postoperatively]

Критерии участия

Критерии включения

  • a. primary knee osteoarthritis;
  • b. Unilateral primary knee replacement;
  • c. Surgical methods were traditional surgery, surgical robot, computer navigation or personalized osteotomy guide

Критерии исключения

  • a. A history of renal insufficiency (Cr > 2.5), liver insufficiency, severe heart disease (or coronary stenting within the last 12 months), severe respiratory disease, history of VTE or high risk of thrombosis (hereditary/acquired thrombotic disease), cotting disorder, stroke, and malignancy;
  • b. Those who do not accept this test for any reason and refuse to sign the informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT06010979 · TKAcohort

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗