Lumbar Spinal StenosisNCT06593574
Safety and Effectiveness Evaluation of Spinal Laminectomy Robot
A study testing Robotic laminectomy and Traditional laminectomy in people with Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by Peking University Third Hospital at 3 sites in China.
Trial summary
The purpose of this clinical trial is to evaluate the effectiveness and safety of this spinal robot in assisting doctors to perform laminectomy in spinal surgery under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Disc Herniation
- What is being tested?
- Robotic laminectomy and Traditional laminectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesChina
- Study dates
- 15 Oct 2024to 30 Dec 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years old (including 18 and 80 years old), regardless of gender;
- Patients with complete clinical data, willing and able to sign informed consent;
- Patients with lumbar disc herniation, lumbar spinal stenosis, lumbar instability, lumbar spondylolisthesis, and lumbar fracture meet the indications for spinal laminectomy and undergoing open surgery；
- Patients with lumbar disc herniation, lumbar spinal stenosis, or lumbar instability have one of the following:
- It was not effective after 3 months of conservative treatment
- Symptoms seriously affect the quality of life
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- cauda equina nerve injury
- Lumbar spondylolisthesis occurs in one of the following:
- Symptoms of II° and below slip were not relieved by non-surgical treatment
- Lumbar spondylolisthesis III° and above
- Symptoms of lumbar spinal stenosis
- The TLISS score of lumbar spine fracture is greater than or equal to 4 points.
Who cannot join
- Patients who are not suitable for robot-assisted surgery;
- Patients with existing implants in or near the vertebral body of the lesion;
- Patients whose vertebral lamina bone tissue of the focal vertebra or adjacent vertebra has been removed;
- Pregnant and lactating female patients;
- the subject is unwilling or unable to restrict activities or follow medical advice;
- Patients with infection near the focal area;
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- The patient is mentally incapable or unable to understand the requirements for participating in the study;
- The patient is critically ill, the expected survival period is not more than 2 years, and it is difficult to make an accurate assessment of the effectiveness and safety of the device;
- Patients with coagulation dysfunction;
- Other researchers did not consider it suitable for admission.
Trial locations and contacts
3 sites in 1 country.
Zhuofu Li, M.D. contact
China3 sites, 3 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100101
Weishi Li, MD
- Not yet recruiting
Third Affiliated hospital of Southern medical university
Guangzhou
Qingchu Li
- Not yet recruiting
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou
Yu Qian
About this study
Official title: A Multicenter, Randomized, Blind Evaluation, Parallel-controlled, Superiority Clinical Trial of Spinal Robot System for Safety and Efficacy Evaluation of Assisted Laminectomy
The purpose of this clinical trial is to evaluate the effectiveness and safety of this spinal robot in assisting doctors to perform laminectomy in spinal surgery under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial.
Read the detailed description
This is a multicenter, randomized, blind evaluation, parallel-controlled, and superiority clinical trial. The objective of this study is to evaluate the effectiveness and safety of a spinal robot in assisting surgeons in laminectomy. The experiment included 3 centers with a total sample size of 70. The experimental group is the robot laminectomy group (RL group), and the control group is the manual laminectomy group (ML group). Laminectomy in the RL group is performed robotically, while laminectomy in the ML group is performed by the physician using an ultrasonic osteotome. The primary outcome measure is the accuracy of laminectomy. Secondary outcome measures included JOA score, VAS score, laminectomy success rate, laminectomy time per spinal segment, total laminectomy time, operative time, amount of surgical bleeding, number of X-ray exposures and total dose, and planned area excision rate. The evaluation was completed by comparing the outcomes between the two groups.
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation
- Being tested
- Robotic laminectomy, Traditional laminectomy
- Keywords
- Spinal robot, Laminectomy
- 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.
Robotic laminectomyProcedure or surgery
Surgical robots are used to assist with laminectomy
Traditional laminectomyProcedure or surgery
Instead of relying on a surgical robot, doctors perform the laminectomy themselves with an ultrasonic osteotome
| Study group | Role | What they receive |
|---|---|---|
| Robotic laminectomy group | Experimental | The laminectomy is performed with the assistance of a robot Receives: Procedure: Robotic laminectomy |
| Manual laminectomy group | Active comparator | The laminectomy is performed by the surgeon without the assistance of a robot Receives: Procedure: Traditional laminectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy rate of laminectomy
According to the classification criteria for the accuracy of laminectomy proposed by Zhuofu Li, grade A indicates that the pre-planned cutting lines are basically located in the actual cutting groove or that the maximum distance between them is <1mm; Grade B indicates that the maximum distance between the pre-planned cutting line and the actual cutting groove is 1 to 2mm. Grade C indicates a maximum distance of >2 mm between the two. Grades A and B are acceptable. The percentage of A+B in the total number of planned boundaries was counted as the accuracy rate of laminectomy.
Measured: Immediately after the intraoperative laminectomy procedure
Secondary outcomes (7)
Success rate of laminectomy
After the laminectomy is complete, check whether the laminectomy can be successfully removed. Each cutting plane is evaluated individually.
Measured: Immediately after the intraoperative laminectomy procedure
Improvement rate of Japanese Orthopaedic Society (JOA) Score
The JOA score is a scoring system used to assess lumbar dysfunction. The lumbar JOA score includes subjective symptoms (9), clinical signs (6), limits of daily activities (14), and bladder function (-6 to 0) on a 29-point scale. The lower the score, the more significant the dysfunction.
Improvement rate = [(post-treatment score - pre-treatment score)/(29 - pre-treatment score)] × 100%.
Measured: JOA scores were used to evaluate experimental and control subjects before and one month after surgery.
Visual analogue scale (VAS)
Visual analog scale, which indicates the degree of pain. The VAS score was used to evaluate the pain degree of the experimental group and control group.
Measured: Before and one month after the operation
Laminectomy time per spinal segment
Laminectomy time for a single spinal segment = total laminectomy time ÷ Number of spinal segments with laminectomy.
Measured: Immediately after surgery.
Total laminectomy time
The time from the start of laminectomy until the tool stops working is denoted as the total laminectomy time.
Measured: Immediately after surgery.
Operative time
From the time the skin is cut to the time the suture is finished.
Measured: Immediately after surgery.
Amount of surgical bleeding
Amount of surgical bleeding
Measured: Immediately after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Oct 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 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.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated Hospital of Southern Medical University, The First Affiliated Hospital of Zhejiang Chinese Medical University
- Responsible party
- Sponsor
- Investigators
- Weishi Li, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593574
- Sponsor's protocol ID
- D2024096
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 22 Oct 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Blind Evaluation, Parallel-controlled, Superiority Clinical Trial of Spinal Robot System for Safety and Efficacy Evaluation of Assisted Laminectomy
- ClinicalTrials.gov ID
- NCT06593574
- Acronym / sponsor ID
- D2024096
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation
- Keywords
- Spinal robot, Laminectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- The Third Affiliated Hospital of Southern Medical University, The First Affiliated Hospital of Zhejiang Chinese Medical University
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Sep 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 purpose of this clinical trial is to evaluate the effectiveness and safety of this spinal robot in assisting doctors to perform laminectomy in spinal surgery under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial.
Detailed description
This is a multicenter, randomized, blind evaluation, parallel-controlled, and superiority clinical trial. The objective of this study is to evaluate the effectiveness and safety of a spinal robot in assisting surgeons in laminectomy. The experiment included 3 centers with a total sample size of 70. The experimental group is the robot laminectomy group (RL group), and the control group is the manual laminectomy group (ML group). Laminectomy in the RL group is performed robotically, while laminectomy in the ML group is performed by the physician using an ultrasonic osteotome. The primary outcome measure is the accuracy of laminectomy. Secondary outcome measures included JOA score, VAS score, laminectomy success rate, laminectomy time per spinal segment, total laminectomy time, operative time, amount of surgical bleeding, number of X-ray exposures and total dose, and planned area excision rate. The evaluation was completed by comparing the outcomes between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic laminectomy group | Experimental | Procedure: Robotic laminectomyThe laminectomy is performed with the assistance of a robot |
| Manual laminectomy group | Active comparator | Procedure: Traditional laminectomyThe laminectomy is performed by the surgeon without the assistance of a robot |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients aged 18-80 years old (including 18 and 80 years old), regardless of gender;
- Patients with complete clinical data, willing and able to sign informed consent;
- Patients with lumbar disc herniation, lumbar spinal stenosis, lumbar instability, lumbar spondylolisthesis, and lumbar fracture meet the indications for spinal laminectomy and undergoing open surgery；
- Patients with lumbar disc herniation, lumbar spinal stenosis, or lumbar instability have one of the following:
- Lumbar spondylolisthesis occurs in one of the following:
Key exclusion criteria (10 listed)
- Patients who are not suitable for robot-assisted surgery;
- Patients with existing implants in or near the vertebral body of the lesion;
- Patients whose vertebral lamina bone tissue of the focal vertebra or adjacent vertebra has been removed;
- Pregnant and lactating female patients;
- the subject is unwilling or unable to restrict activities or follow medical advice;
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 |
|---|---|---|
| Robotic laminectomySurgical robots are used to assist with laminectomy | Procedure or surgery | Robotic laminectomy group |
| Traditional laminectomyInstead of relying on a surgical robot, doctors perform the laminectomy themselves with an ultrasonic osteotome | Procedure or surgery | Manual laminectomy group |
Primary outcome
Accuracy rate of laminectomy
Time frame: Immediately after the intraoperative laminectomy procedure
According to the classification criteria for the accuracy of laminectomy proposed by Zhuofu Li, grade A indicates that the pre-planned cutting lines are basically located in the actual cutting groove or that the maximum distance between them is <1mm; Grade B indicates that the maximum distance between the pre-planned cutting line and the actual cutting groove is 1 to 2mm. Grade C indicates a maximum distance of >2 mm between the two. Grades A and B are acceptable. The percentage of A+B in the total number of planned boundaries was counted as the accuracy rate of laminectomy.
7 secondary outcomes
Success rate of laminectomy
Time frame: Immediately after the intraoperative laminectomy procedure
Improvement rate of Japanese Orthopaedic Society (JOA) Score
Time frame: JOA scores were used to evaluate experimental and control subjects before and one month after surgery.
Visual analogue scale (VAS)
Time frame: Before and one month after the operation
Laminectomy time per spinal segment
Time frame: Immediately after surgery.
Total laminectomy time
Time frame: Immediately after surgery.
Operative time
Time frame: Immediately after surgery.
Amount of surgical bleeding
Time frame: Immediately after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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.
Zhuofu Li, M.D. contact
Weishi Li, M.D. principal investigator
Peking University Third Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic laminectomy and Traditional laminectomy in people with Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by Peking University Third Hospital at 3 sites 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 12 inclusion and 10 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 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Weishi Li, M.D. ((+86010)62017691-7011, puh3liweishi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy rate of laminectomy (time frame: Immediately after the intraoperative laminectomy procedure). 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 22 Oct 2024.