Safety and Effectiveness Evaluation of Spinal Laminectomy Robot

NCT06593574 | Recruiting

• 1 other identifier: D2024096
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Lumbar Spinal Stenosis; Lumbar Disc Herniation

Keywords

Spinal robot; Laminectomy

Outcome Measures

Primary Outcomes (1)

• Accuracy rate of laminectomy

  According to the classification criteria for the accuracy of laminectomy proposed by Zhuofu Li, grade A indicates that the pre-planned cutting lines are basically located in the actual cutting groove or that the maximum distance between them is \<1mm; Grade B indicates that the maximum distance between the pre-planned cutting line and the actual cutting groove is 1 to 2mm. Grade C indicates a maximum distance of \>2 mm between the two. Grades A and B are acceptable. The percentage of A+B in the total number of planned boundaries was counted as the accuracy rate of laminectomy.

  Immediately after the intraoperative laminectomy procedure

Secondary Outcomes (7)

• Success rate of laminectomy

  Immediately after the intraoperative laminectomy procedure

• Improvement rate of Japanese Orthopaedic Society (JOA) Score

  JOA scores were used to evaluate experimental and control subjects before and one month after surgery.

• Visual analogue scale (VAS)

  Before and one month after the operation

• Laminectomy time per spinal segment

  Immediately after surgery.

• Total laminectomy time

  Immediately after surgery.

Study Arms (2)

Robotic laminectomy group

EXPERIMENTAL

The laminectomy is performed with the assistance of a robot

Procedure: Robotic laminectomy

Manual laminectomy group

ACTIVE COMPARATOR

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

Procedure: Traditional laminectomy

Interventions

Robotic laminectomy PROCEDURE

Surgical robots are used to assist with laminectomy

Robotic laminectomy group

Traditional laminectomy PROCEDURE

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

Manual laminectomy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• The Third Affiliated Hospital of Southern Medical University: collaborator
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator

Study Sites (3)

Peking University Third Hospital

Beijing, 100101, 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

MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Weishi Li, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weishi Li, M.D.

CONTACT

(+86010)62017691-7011; puh3liweishi@163.com

Zhuofu Li, M.D.

CONTACT

bjmulizhuofu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: October 15, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)