Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416631
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-27
Brief Title:
Artificial Intelligence Versus Maunal Planning in Robot Assisted Spinal Surgery
Sponsor:
Beijing Jishuitan Hospital
Organization:
Beijing Jishuitan Hospital
Study Overview
Official Title:
Artificial Intelligence Versus Manual Planning in Patients Undergoing Robot-assisted Pedicle Screw Internal Fixation a Prospective Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if the artificial intelligence technology helps to improve the efficiency in robot assited spinal surgery The main questions it aims to answer are
Does the AI technology shorter the mannual planning time of screw trajectories Does the AI technology affect the surgical accuracy Researchers will compare the artificial intelligence technology to the conventional mannual planning in robotic surgery
Participants who met inclusion criteria and do not have any exclusion criterion will be randomized to artificial intelligence or mannual planning group
Does the AI technology shorter the mannual planning time of screw trajectories Does the AI technology affect the surgical accuracy Researchers will compare the artificial intelligence technology to the conventional mannual planning in robotic surgery
Participants who met inclusion criteria and do not have any exclusion criterion will be randomized to artificial intelligence or mannual planning group
Detailed Description:
Study design
multicenter non-inferiority open-label randomized controlled trial in patients undergoing robotic spinal surgery
Monitoring
Monitoring of patients safety and effectiveness data is performed by a designated independent Data Safety and Monitoring Board DSMB The DSMB watches over the ethics of conducting the study in accordance with the Declaration of Helsinki
Sample Size Calculation
Group size calculation is focused on demonstrating non-inferiority Assuming that the percentage of clinically acceptable screws would be 90 in the artificial intelligence planning group and 95 in the manual planning group with a non-inferiority margin of 10 and a one-sided significance level of 25 we calculated that a sample of 79 screws per treatment group would give the trial approximately 95 power to show noninferiority of artificial intelligence planning group to manual planning group with regard to the primary end point
multicenter non-inferiority open-label randomized controlled trial in patients undergoing robotic spinal surgery
Monitoring
Monitoring of patients safety and effectiveness data is performed by a designated independent Data Safety and Monitoring Board DSMB The DSMB watches over the ethics of conducting the study in accordance with the Declaration of Helsinki
Sample Size Calculation
Group size calculation is focused on demonstrating non-inferiority Assuming that the percentage of clinically acceptable screws would be 90 in the artificial intelligence planning group and 95 in the manual planning group with a non-inferiority margin of 10 and a one-sided significance level of 25 we calculated that a sample of 79 screws per treatment group would give the trial approximately 95 power to show noninferiority of artificial intelligence planning group to manual planning group with regard to the primary end point
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None