Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty

Официальное название

Comparison of Clinical Efficacy and Safety of Robot-assisted Total Knee Arthroplasty and Conventional Total Knee Arthroplasty: a Randomized Controlled Study

Обзор

The purpose of this clinical trial is to understand the application value of the Orthopedic Joint Surgery Navigation System in assisting surgeons to accurately place prosthetic components in adult knee replacement surgery. It will also confirm its effectiveness and safety in clinical application.

Подробное описание

The purpose of this clinical trial is to understand the application value of the Orthopedic Joint Surgery Navigation System in assisting surgeons to accurately place prosthetic components in adult knee replacement surgery. It will also confirm its effectiveness and safety in clinical application. The main questions it aims to answer are:

Does the Orthopedic Joint Surgery Navigation System improve the accuracy of prosthetic component placement in knee replacement surgery? Is the Orthopedic Joint Surgery Navigation System superior to traditional total knee replacement What medical problems do participants encounter when taking medication ABC? Researchers will compare the Orthopedic Joint Surgery Navigation System with traditional total knee replacement surgery (using a "four-in-one" osteotomy guide) to see if the Orthopedic Joint Surgery Navigation System is superior to traditional total knee replacement in terms of prosthesis three-dimensional position, force alignment, patient satisfaction, functional scores, complications, etc.

Participants will:

End-stage knee osteoarthritis patients receive total knee replacement with the Orthopedic Joint Surgery Navigation System or traditional total knee replacement surgery Visit the clinic for examination and testing every 3 months Record their imaging data, satisfaction, functional scores, complications, etc.

Вмешательства

• Процедура Robot-assisted surgery
  Orthopedic surgeons perform total knee arthroplasty using an orthopedic joint surgery navigation system
• Процедура Conventional total knee arthroplasty
  Orthopedic surgeons perform total knee arthroplasty using a 4 in 1 osteotomy guide

Первичные конечные точки

• Postoperative patient satisfaction [Срок оценки: Month 1, Month 3, Month 6, Month 12, Month 24]
• Forgotten Joint Scores [Срок оценки: Month 1, Month 3, Month 6, Month 12, Month 24]
• WOMAC score [Срок оценки: Month 1, Month 3, Month 6, Month 12, Month 24]
• Knee Society Score [Срок оценки: Month 1, Month 3, Month 6, Month 12, Month 24]

Вторичные конечные точки (5)

• SF-12 [Срок оценки: Month 1, Month 3, Month 6, Month 12, Month 24]
• visual analogue scale score [Срок оценки: Month 1, Month 3, Month 6, Month 12, Month 24]
• Range of motion [Срок оценки: Month 1, Month 3, Month 6, Month 12, Month 24]
• Hip-knee-ankle angle [Срок оценки: postoperative Day 1-3]
• Complication [Срок оценки: Month 1, Month 3, Month 6, Month 12, Month 24]

Критерии участия

Критерии включения

• Subjects voluntarily participate in the trial and sign the informed consent form;
• Aged 18 to 80 years old (inclusive), regardless of gender;
• Patients who need total knee replacement surgery;
• Those who can communicate well with the researchers and comply with the trial requirements.

Критерии исключения

• Patients who are allergic to the drugs used in this trial or the implant materials;
• Patients with immature bone development;
• Patients with active infection;
• Patients with neuropathy of the knee joint;
• Patients with poor bone quality that is not conducive to prosthesis fixation;
• Patients with general conditions or concomitant diseases that make it difficult for people to tolerate surgery;
• Patients with insufficient quadriceps muscle strength;
• Patients with insufficient skin coverage near the surgical site and intolerance to surgery;
• Patients with severe femoral or tibial deformities and other severe deformities outside the joint;
• Patients with metal implants in the joint surgical area that affect the execution of the surgical plan;
• Pregnant or lactating women;
• Patients with severe epilepsy or mental illness;
• Patients with alcohol dependence or drug addiction;
• Patients with severe coagulation disorders;
• Patients who have participated in or are participating in other clinical trials within one month of enrollment;
• Patients who are considered by the researchers to be unsuitable for participating in this clinical trial for other reasons. Those who meet any of the above exclusion criteria need to be excluded.

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

Китай · 1 центр

• the first affiliated hospital of USTC — Хэфэй

Идентификаторы

NCT: NCT06856356 · XJS2023-1-18(WK)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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