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

Last updated: June 24, 2024
Sponsor: Beijing Jishuitan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Stenosis

Radiculopathy

Spondylolisthesis

Treatment

endoscopic spine surgery

Clinical Study ID

NCT06480214
ZLRK202309
  • Ages 18-85
  • All Genders

Study Summary

The aim of the study was to investigate the correlation between the extent of decompression and patient follow-up metrics at 1 year postoperatively by analysing data from a real-world, multicentre cohort of patients, and to clarify the precise extent of decompression for endoscopic spine surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with lumbar spinal stenosis or lumbar disc herniation with narrow centralcanal and lateral recess of single lumbar vertebra;

  2. formal conservative treatment is ineffective for at least 3 months;

  3. Voluntary surgery and follow-up for more than 6 months;

  4. Sign informed consent.

  5. The patient is > 18 years old and has the ability to act autonomously.

Exclusion

Exclusion Criteria:

  1. Previous history of lumbar surgery; 2, combined with lumbar spondylolisthesis,lumbar instability or spinal deformity; 3, there are surgical contraindications, cannot perform surgery; 4, can not follow up on time after surgery or lost visitors.

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: endoscopic spine surgery
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
December 01, 2025

Study Description

In recent years, endoscopic spine surgery has developed rapidly, especially in the treatment of degenerative spinal diseases. Minimally invasive endoscopic spine surgery has been widely implemented and promoted in hospitals at all levels. The learning curve of endoscopic spinal surgery is steep because it is performed in a narrow space adjacent to sensitive structures such as nerves and blood vessels. The surgical effect completely depends on the experience of the surgeon. How to break through the bottleneck and forbidden zone of endoscopic spine surgery and establish a perfect treatment system for endoscopic spine surgery has become one of the urgent problems and challenges in current spine surgery. At present, enabling technologies such as artificial intelligence, computer-assisted surgical navigation and robotics have been applied in spinal surgery, but their functions are limited to stereotactic orientation. Endoscopic spinal surgery robots that can meet the needs of intelligent surgical planning, precise decompression and flexible micromanipulation under endoscope are still lacking in the world. It is of great practical significance to develop an endoscopic spinal surgery robot platform with artificial intelligence characteristics, and based on this, establish an endoscopic spinal surgery treatment system oriented by accurate, safe and effective improvement of patient clinical outcomes, which is expected to improve the level of diagnosis and treatment of spinal surgery and promote the transformation and industrialization of a new generation of surgical technology. The objectives of this project include: 1) to conduct a real-world study on the precise decompression range of endoscopic spine surgery, to investigate the artificial intelligence-assisted spinal segmentation and automatic decompression planning for endoscopic spine surgery; 2) Develop a new generation of small interactive intelligent endoscopic robot system and supporting new minimally invasive surgical instruments, and study the human-computer interaction control strategy suitable for narrow space; 3) Carry out the effectiveness and safety research of the endoscopic spinal surgery robot, and verify it in model bones, animal bones and humans in general. The products are approved and clinical trials are completed after the relevant parts are filed. Finally, a small interactive endoscopic surgery robot platform and an intelligent decompression planning system were successfully developed, which clarified the scope and operation specification of accurate endoscopic decompression, provided guidance for the popularization of endoscopic surgery, and formed the operation process specification of small interactive minimally invasive endoscopic surgery.

Connect with a study center

  • Beijing Jishuitan Hospital, Capital Medical University

    Beijing, Beijing 330000
    China

    Active - Recruiting

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