Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593574
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Safety and Effectiveness Evaluation of Spinal Laminectomy Robot
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Blind Evaluation Parallel-controlled Superiority Clinical Trial of Spinal Robot System for Safety and Efficacy Evaluation of Assisted Laminectomy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None