Artificial Intelligence Versus Maunal Planning in Robot Assisted Spinal Surgery

NCT ID: NCT06416631

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-25
• Study Completion Date: 2026-05-01

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.

Detailed Description

Study design:

multicenter, non-inferiority, open-label, randomized controlled trial in patients undergoing robotic spinal surgery.

Monitoring:

Monitoring of patient's 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 2.5%, 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.

Conditions

Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

artificial intelligence planning group

Group Type: EXPERIMENTAL

artificial intelligence based screw planning

Intervention Type: PROCEDURE

artificial intelligence technology helps to plan screws in robot assisted spinal surgery

manual planning group

Group Type: PLACEBO_COMPARATOR

manually screw planning

Intervention Type: PROCEDURE

the screw trajcetories are manually planned

Interventions

artificial intelligence based screw planning

artificial intelligence technology helps to plan screws in robot assisted spinal surgery

Intervention Type: PROCEDURE

manually screw planning

the screw trajcetories are manually planned

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Admission to one of the participating centers；
• Need for and start of robotic spinal surgery
• Patients had complete medical records and imaging data;

Exclusion Criteria

• Age less than 18 years;
• Patients with severe comorbidities;
• Patients diagnosed with tumor diseases;
• Inability to carry out the intervention (mental of physical conditions that limited participation);
• Patients with morbid obesity (body mass index > 40);
• Missing medical records and imaging data;
• Patients with suspected or confirmed pregnancy;
• Patients participating in another RCT with the same clinical endpoint, or interventions possibly compromising the primary outcome;
• No informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Jishuitan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

AI-RASS

Identifier Type: -

Identifier Source: org_study_id