Safety and Effectiveness Evaluation of Spinal Laminectomy Robot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Research on Key Technology Development and Clinical Application of Small Interactive Spinal Endoscopic Surgery Robot

NCT06480214

Lumbar Spinal Stenosis Lumbar Disc Herniation

RECRUITING

5G-based Telerobot-assisted Spine Surgery

NCT05545709

Surgery

COMPLETED

Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery

NCT04956588

Spine Disease Spinal Fractures

COMPLETED PHASE3

Clinical Trial of Minimally Invasive Robotic Spine Surgery

NCT02121249

Degenerative Lumbar Spinal Stenosis

COMPLETED NA

Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy

NCT02358291

Lumbar Disc Herniation

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Spinal Stenosis Lumbar Disc Herniation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robotic laminectomy group

The laminectomy is performed with the assistance of a robot

Group Type EXPERIMENTAL

Robotic laminectomy

Intervention Type PROCEDURE

Surgical robots are used to assist with laminectomy

Manual laminectomy group

The laminectomy is performed by the surgeon without the assistance of a robot

Group Type ACTIVE_COMPARATOR

Traditional laminectomy

Intervention Type PROCEDURE

Instead of relying on a surgical robot, doctors perform the laminectomy themselves with an ultrasonic osteotome

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robotic laminectomy

Surgical robots are used to assist with laminectomy

Intervention Type PROCEDURE

Traditional laminectomy

Instead of relying on a surgical robot, doctors perform the laminectomy themselves with an ultrasonic osteotome

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No