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| Name | Class |
|---|---|
| The Third Affiliated Hospital of Southern Medical University | OTHER_GOV |
| The First Affiliated Hospital of Zhejiang Chinese Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic laminectomy group | Experimental | The laminectomy is performed with the assistance of a robot |
|
| Manual laminectomy group | Active Comparator | The laminectomy is performed by the surgeon without the assistance of a robot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic laminectomy | Procedure | Surgical robots are used to assist with laminectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the intraoperative laminectomy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of laminectomy | After the laminectomy is complete, check whether the laminectomy can be successfully removed. Each cutting plane is evaluated individually. | Immediately after the intraoperative laminectomy procedure |
| Improvement rate of Japanese Orthopaedic Society (JOA) Score |
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Inclusion Criteria:
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:
The TLISS score of lumbar spine fracture is greater than or equal to 4 points.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weishi Li, M.D. | Contact | (+86010)62017691-7011 | puh3liweishi@163.com | |
| Zhuofu Li, M.D. | Contact | bjmulizhuofu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weishi Li, M.D. | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | 100101 | China |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| Traditional laminectomy | Procedure | Instead of relying on a surgical robot, doctors perform the laminectomy themselves with an ultrasonic osteotome |
|
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%. |
| 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. | 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. | 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. | Immediately after surgery. |
| Operative time | From the time the skin is cut to the time the suture is finished. | Immediately after surgery. |
| Amount of surgical bleeding | Amount of surgical bleeding | Immediately after surgery. |
| Third Affiliated hospital of Southern medical university | Not yet recruiting | Guangzhou | China |
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| Zhejiang Provincial Hospital of Chinese Medicine | Not yet recruiting | Hangzhou | China |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |