Safety and Effectiveness Evaluation of Spinal Laminectomy Robot

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new robotic device designed to assist surgeons during spinal surgery, specifically for conditions like lumbar spinal stenosis and lumbar disc herniation. The goal is to see how safe and effective this robot is in helping doctors perform a procedure called laminectomy, which involves removing part of the bone over the spinal canal to relieve pressure on the nerves. The trial is currently recruiting participants aged 18 to 80 who have certain back problems and have not found relief from other treatments.

To participate, individuals should have specific conditions that require surgery and be willing to provide their medical information and consent to join the study. It's important to note that some people may not be eligible, such as those with certain medical conditions or infections. Participants can expect to be monitored closely throughout the trial to ensure their safety and to gather information on how well the robotic assistance works. This research could help improve future spinal surgeries and patient outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • 1. It was not effective after 3 months of conservative treatment
• • 2. Symptoms seriously affect the quality of life
• • 3. cauda equina nerve injury
• * Lumbar spondylolisthesis occurs in one of the following:
• • 1. Symptoms of II° and below slip were not relieved by non-surgical treatment
• • 2. Lumbar spondylolisthesis III° and above
• • 3. Symptoms of lumbar spinal stenosis
• • The TLISS score of lumbar spine fracture is greater than or equal to 4 points.
• Exclusion Criteria:
• • 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.