Artificial Intelligence Versus Maunal Planning in Robot Assisted Spinal Surgery

Not Applicable

Not yet recruiting

• Conditions: Surgery
• Interventions: Procedure: artificial intelligence based screw planning; Procedure: manually screw planning

• Registration Number: NCT06416631
• Lead Sponsor: Beijing Jishuitan Hospital

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-27
• Study First Submitted QC: 2024-05-12
• Last Update Submitted: 2024-05-12
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Study Start: 2024-05-25
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
artificial intelligence planning group	artificial intelligence based screw planning	-
manual planning group	manually screw planning	-

Primary Outcome Measures

Name	Time	Method
The accuracy of screw positioning or placement	1 month	according to the Gertzbein and Robbins scale, including grade A (screw was completely within the pedicle), grade B (pedicle cortical breach \<2 mm), grade C (pedicle cortical breach \<4 mm), grade D (pedicle cortical breach \<6 mm), and grade E (pedicle cortical breach \>6 mm). Grade A + B were considered clinically acceptable. The percentage of clinically acceptable screws was recorded.

Secondary Outcome Measures

Name	Time	Method
The planning time	1 day	Time from start to finish of planning
postoperative complication	3 month	Nerve injury, epidural hematoma, and infection