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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Disc Herniation; Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: endoscopic spine surgery

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Yajun Liu; Phone Number: +86 139 1187 8647; Email: drliuyajun@163.com
• Study Contact Backup: Name: Wenkai Wu; Phone Number: +86 153 2043 6766; Email: wenkai_wu@outlook.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 330000
      • Recruiting
      • Beijing Jishuitan Hospital, Capital Medical University
      • Contact: Yajun Liu; Phone Number: +86 139 1187 8647; Email: drliuyajun@163.com
      • Contact: Wenkai Wu; Phone Number: +86 153 2043 6766; Email: wenkai_wu@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

According to the inclusion and exclusion criteria, the number of patients with lumbar spinal stenosis or lumbar disc herniation who underwent endoscopic spinal surgery during 2021-2023 was determined, and the number of patients in the multi-center was not less than 1000

Description

Inclusion Criteria:

1. Patients with lumbar spinal stenosis or lumbar disc herniation with narrow central canal 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 Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative 1-year incidence of complications	the incidence of complications such as neural injury, postoperative bleeding, dural tear, wound infection etc, 1 year after the operation	1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative lumbar spine function score	We would measure the lumbar spine function score, such as SSM (Spinal Stenosis Measure), JOA (Japanese Orthopaedic Association), ODI (Oswestry Disability Index) and VAS (Visual Analog Scale), after surgery. Higher scores of SSM, JOA, ODI and VAS means worse outcome.	1 year
Range of bony decompression of the lumbar spinal canal	The range of decompression of the bone structures during the surgery	1 year
Surgical level lumbar spinal canal area	The level of lumbar spinal canal in the surgery	1 year
White-Panjabi score for lumbar spine stability	White-Panjabi score was used to evaluate the lumbar spine stability. Higher scores of Panjabi score means higher levels of spine instability	1 year
Weishupt score for degeneration of the small joints of the lumbar spine	Weishupt score was used to evaluate the degree of degeneration of the small joints of the lumbar spine. Higher scores of Weishupt score means higher levels of spine degeneration	1 year
Degree of fatty infiltration of lumbar spine muscles	Degree of fatty infiltration is measured by MRI scanning	1 year
Lumbar spine mobility and isometric muscle strength	The measurement of muscle mobidity and strength	1 year
Post-operative recurrence rate	The recurrence rate after surgery	1 year
Post-operative reoperation rate	the reoperation rate in the 1-year postoperation period	1 year
Record of postoperative rehabilitation exercises	rehabilitation exercises patients made after surgery	1 year

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Collaborators: Beijing Friendship Hospital; The Affiliated Hospital of Qingdao University; Beijing Chao Yang Hospital; The Seventh Affiliated Hospital of Sun Yat-sen University; Beijing Haidian Hospital; Liaocheng People's Hospital; Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital; Emergency General Hospital; Guizhou Orthopedics Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Spinal Stenosis
• Other Study ID Numbers: ZLRK202309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No