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Lumbar Spinal StenosisNCT06480214

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

An observational study of Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by Beijing Jishuitan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
endoscopic spine surgery
Type of treatment
Surgery or procedure
How many people
1,000 participants
Where
1 siteChina
Study dates
1 Jan 2023to 1 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Beijing Jishuitan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 330000

    Yajun Liu, 139 1187 8647 ext. +86, drliuyajun@163.com

    Wenkai Wu, 153 2043 6766 ext. +86, wenkai_wu@outlook.com

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Being tested
endoscopic spine surgery
Medical subject headings
Spinal Stenosis, Intervertebral Disc Displacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endoscopic spine surgeryProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year after surgery

Secondary outcomes (10)
  1. 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.

    Measured: 1 year

  2. Range of bony decompression of the lumbar spinal canal

    The range of decompression of the bone structures during the surgery

    Measured: 1 year

  3. Surgical level lumbar spinal canal area

    The level of lumbar spinal canal in the surgery

    Measured: 1 year

  4. 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

    Measured: 1 year

  5. 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

    Measured: 1 year

  6. Degree of fatty infiltration of lumbar spine muscles

    Degree of fatty infiltration is measured by MRI scanning

    Measured: 1 year

  7. Lumbar spine mobility and isometric muscle strength

    The measurement of muscle mobidity and strength

    Measured: 1 year

  8. Post-operative recurrence rate

    The recurrence rate after surgery

    Measured: 1 year

  9. Post-operative reoperation rate

    the reoperation rate in the 1-year postoperation period

    Measured: 1 year

  10. Record of postoperative rehabilitation exercises

    rehabilitation exercises patients made after surgery

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2024
  2. Study start1 Jan 2023
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06480214
Sponsor's protocol ID
ZLRK202309
Status last verified
Apr 2024
First submitted
13 May 2024
Last updated
28 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by Beijing Jishuitan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yajun Liu (139 1187 8647 ext. +86, drliuyajun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative 1-year incidence of complications (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.

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