Clinical trial NCT06480214: Research on Key Technology Development and Clinical Application of Small Interactive Spinal Endoscopic Surgery Robot
Official title: Research on Key Technology Development and Clinical Application of Small Interactive Spinal Endoscopic Surgery Robot
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Spinal Stenosis
Lumbar Disc Herniation
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Beijing Friendship Hospital
name: Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital
name: Beijing Haidian Hospital
name: Emergency General Hospital
name: The Seventh Affiliated Hospital of Sun Yat-sen University
name: Guizhou Orthopedics Hospital
name: The Affiliated Hospital of Qingdao University
name: Liaocheng People's Hospital
First posted: 2024-06-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative 1-year incidence of complications
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Postoperative lumbar spine function score
timeFrame: 1 year
measure: Range of bony decompression of the lumbar spinal canal
timeFrame: 1 year
measure: Surgical level lumbar spinal canal area
timeFrame: 1 year
measure: White-Panjabi score for lumbar spine stability
timeFrame: 1 year
measure: Weishupt score for degeneration of the small joints of the lumbar spine
timeFrame: 1 year
measure: Degree of fatty infiltration of lumbar spine muscles
timeFrame: 1 year
measure: Lumbar spine mobility and isometric muscle strength
timeFrame: 1 year
measure: Post-operative recurrence rate
timeFrame: 1 year
measure: Post-operative reoperation rate
timeFrame: 1 year
measure: Record of postoperative rehabilitation exercises
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital, Capital Medical University
state: Beijing
Study officials:
References: