Evaluation of a robotic system for spinal laminectomy

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

This study is testing a new robotic system to see if it can help surgeons perform spinal surgery more safely and effectively than traditional methods for patients with back problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Locations: 3 sites (Beijing and 2 other locations)
• Trial ID: NCT06593574 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of a robotic system designed to assist surgeons in performing laminectomy for conditions such as lumbar spinal stenosis and lumbar disc herniation. It is a multicenter, randomized, and controlled trial involving 70 participants, divided into two groups: one receiving robotic-assisted surgery and the other undergoing traditional manual surgery. The primary focus is on measuring the accuracy of the laminectomy procedure, while secondary outcomes include various metrics such as surgical time, bleeding, and patient recovery scores. The trial seeks to ensure that the robotic approach is both safe and scientifically valid compared to conventional methods.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with lumbar disc herniation or spinal stenosis who have not responded to conservative treatment and require surgical intervention.

Not a fit: Patients with conditions not suitable for laminectomy or those who have not met the criteria for surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this robotic system could enhance surgical precision and improve recovery outcomes for patients undergoing laminectomy.

How similar studies have performed: Other studies have shown promising results with robotic-assisted surgeries, indicating potential for success in this novel approach.

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.

Where this trial is running

Beijing and 2 other locations

• Peking University Third Hospital — Beijing, China (Recruiting)
• Third Affiliated hospital of Southern medical university — Guangzhou, China (Not_yet_recruiting)
• Zhejiang Provincial Hospital of Chinese Medicine — Hangzhou, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Weishi Li, M.D. — Peking University Third Hospital
• Study coordinator: Weishi Li, M.D.

Conditions Lumbar Spinal Stenosis; Lumbar Disc Herniation; Spinal robot; Laminectomy