Safety and Effectiveness Evaluation of Spinal Laminectomy Robot

Официальное название

A Multicenter, Randomized, Blind Evaluation, Parallel-controlled, Superiority Clinical Trial of Spinal Robot System for Safety and Efficacy Evaluation of Assisted Laminectomy

Обзор

The purpose of this clinical trial is to evaluate the effectiveness and safety of this spinal robot in assisting doctors to perform laminectomy in spinal surgery under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial.

Подробное описание

This is a multicenter, randomized, blind evaluation, parallel-controlled, and superiority clinical trial. The objective of this study is to evaluate the effectiveness and safety of a spinal robot in assisting surgeons in laminectomy. The experiment included 3 centers with a total sample size of 70. The experimental group is the robot laminectomy group (RL group), and the control group is the manual laminectomy group (ML group). Laminectomy in the RL group is performed robotically, while laminectomy in the ML group is performed by the physician using an ultrasonic osteotome. The primary outcome measure is the accuracy of laminectomy. Secondary outcome measures included JOA score, VAS score, laminectomy success rate, laminectomy time per spinal segment, total laminectomy time, operative time, amount of surgical bleeding, number of X-ray exposures and total dose, and planned area excision rate. The evaluation was completed by comparing the outcomes between the two groups.

Вмешательства

• Процедура Robotic laminectomy
  Surgical robots are used to assist with laminectomy
• Процедура Traditional laminectomy
  Instead of relying on a surgical robot, doctors perform the laminectomy themselves with an ultrasonic osteotome

Первичные конечные точки

• Accuracy rate of laminectomy [Срок оценки: Immediately after the intraoperative laminectomy procedure]

Вторичные конечные точки (7)

• Success rate of laminectomy [Срок оценки: Immediately after the intraoperative laminectomy procedure]
• Improvement rate of Japanese Orthopaedic Society (JOA) Score [Срок оценки: JOA scores were used to evaluate experimental and control subjects before and one month after surgery.]
• Visual analogue scale (VAS) [Срок оценки: Before and one month after the operation]
• Laminectomy time per spinal segment [Срок оценки: Immediately after surgery.]
• Total laminectomy time [Срок оценки: Immediately after surgery.]
• Operative time [Срок оценки: Immediately after surgery.]
• Amount of surgical bleeding [Срок оценки: Immediately after surgery.]

Критерии участия

Критерии включения

• Patients aged 18-80 years old (including 18 and 80 years old), regardless of gender;
• Patients with complete clinical data, willing and able to sign informed consent;
• Patients with lumbar disc herniation, lumbar spinal stenosis, lumbar instability, lumbar spondylolisthesis, and lumbar fracture meet the indications for spinal laminectomy and undergoing open surgery；
• Patients with lumbar disc herniation, lumbar spinal stenosis, or lumbar instability have one of the following:

• It was not effective after 3 months of conservative treatment
• Symptoms seriously affect the quality of life
• cauda equina nerve injury
• Lumbar spondylolisthesis occurs in one of the following:

• Symptoms of II° and below slip were not relieved by non-surgical treatment
• Lumbar spondylolisthesis III° and above
• Symptoms of lumbar spinal stenosis
• The TLISS score of lumbar spine fracture is greater than or equal to 4 points.

Критерии исключения

• Patients who are not suitable for robot-assisted surgery;
• Patients with existing implants in or near the vertebral body of the lesion;
• Patients whose vertebral lamina bone tissue of the focal vertebra or adjacent vertebra has been removed;
• Pregnant and lactating female patients;
• the subject is unwilling or unable to restrict activities or follow medical advice;
• Patients with infection near the focal area;
• The patient is mentally incapable or unable to understand the requirements for participating in the study;
• The patient is critically ill, the expected survival period is not more than 2 years, and it is difficult to make an accurate assessment of the effectiveness and safety of the device;
• Patients with coagulation dysfunction;
• Other researchers did not consider it suitable for admission.

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

Китай · 3 центра

• Peking University Third Hospital — Пекин
• Third Affiliated hospital of Southern medical university — Гуанчжоу
• Zhejiang Provincial Hospital of Chinese Medicine — Ханчжоу

Идентификаторы

NCT: NCT06593574 · D2024096

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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