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.
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
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Disc Herniation
- 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
- 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
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.
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation
- 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.
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)
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
Range of bony decompression of the lumbar spinal canal
The range of decompression of the bone structures during the surgery
Measured: 1 year
Surgical level lumbar spinal canal area
The level of lumbar spinal canal in the surgery
Measured: 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
Measured: 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
Measured: 1 year
Degree of fatty infiltration of lumbar spine muscles
Degree of fatty infiltration is measured by MRI scanning
Measured: 1 year
Lumbar spine mobility and isometric muscle strength
The measurement of muscle mobidity and strength
Measured: 1 year
Post-operative recurrence rate
The recurrence rate after surgery
Measured: 1 year
Post-operative reoperation rate
the reoperation rate in the 1-year postoperation period
Measured: 1 year
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.
- First posted28 Jun 2024
- Study start1 Jan 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Friendship Hospital, Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital, Beijing Haidian Hospital, Emergency General Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, Guizhou Orthopedics Hospital, The Affiliated Hospital of Qingdao University, Liaocheng People's Hospital
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Key Technology Development and Clinical Application of Small Interactive Spinal Endoscopic Surgery Robot
- ClinicalTrials.gov ID
- NCT06480214
- Acronym / sponsor ID
- ZLRK202309
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Friendship Hospital, Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital, Beijing Haidian Hospital, Emergency General Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, Guizhou Orthopedics Hospital, The Affiliated Hospital of Qingdao University, Liaocheng People's Hospital
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic spine surgerywe would administer the endoscopic spine surgery to patients with Lumbar spinal stenosis and Lumbar disc herniation. | Procedure or surgery | – |
Primary outcome
Postoperative 1-year incidence of complications
Time frame: 1 year after surgery
the incidence of complications such as neural injury, postoperative bleeding, dural tear, wound infection etc, 1 year after the operation
10 secondary outcomes
Postoperative lumbar spine function score
Time frame: 1 year
Range of bony decompression of the lumbar spinal canal
Time frame: 1 year
Surgical level lumbar spinal canal area
Time frame: 1 year
White-Panjabi score for lumbar spine stability
Time frame: 1 year
Weishupt score for degeneration of the small joints of the lumbar spine
Time frame: 1 year
Degree of fatty infiltration of lumbar spine muscles
Time frame: 1 year
Lumbar spine mobility and isometric muscle strength
Time frame: 1 year
Post-operative recurrence rate
Time frame: 1 year
Post-operative reoperation rate
Time frame: 1 year
Record of postoperative rehabilitation exercises
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.