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

NCT06480214 | Recruiting

• 1 other identifier: ZLRK202309
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis; Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Postoperative lumbar spine function score

  1 year

• Range of bony decompression of the lumbar spinal canal

  1 year

• Surgical level lumbar spinal canal area

  1 year

• White-Panjabi score for lumbar spine stability

  1 year

• Weishupt score for degeneration of the small joints of the lumbar spine

  1 year

Interventions

endoscopic spine surgery PROCEDURE

we would administer the endoscopic spine surgery to patients with Lumbar spinal stenosis and Lumbar disc herniation.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with lumbar spinal stenosis or lumbar disc herniation with narrow central canal and lateral recess of single lumbar vertebra;
• formal conservative treatment is ineffective for at least 3 months;
• Voluntary surgery and follow-up for more than 6 months;
• Sign informed consent.
• The patient is \> 18 years old and has the ability to act autonomously.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Jishuitan Hospital, Capital Medical University

Beijing, Beijing Municipality, 330000, China

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

Central Study Contacts

Yajun Liu

CONTACT

139 1187 8647; drliuyajun@163.com

Wenkai Wu

CONTACT

153 2043 6766; wenkai_wu@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 28, 2024
• Study Start: January 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 28, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)