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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Surgical robots are used to assist with laminectomy
Instead of relying on a surgical robot, doctors perform the laminectomy themselves with an ultrasonic osteotome
Peking University Third Hospital
Beijing, China
RECRUITINGThird Affiliated hospital of Southern medical university
Guangzhou, China
NOT_YET_RECRUITINGZhejiang Provincial Hospital of Chinese Medicine
Hangzhou, China
NOT_YET_RECRUITINGAccuracy 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.
Time frame: Immediately after the intraoperative laminectomy procedure
Success rate of laminectomy
After the laminectomy is complete, check whether the laminectomy can be successfully removed. Each cutting plane is evaluated individually.
Time frame: 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%.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Immediately after surgery.
Operative time
From the time the skin is cut to the time the suture is finished.
Time frame: Immediately after surgery.
Amount of surgical bleeding
Amount of surgical bleeding
Time frame: Immediately after surgery.