Artificial Intelligence Versus Maunal Planning in Robot Assisted Spinal Surgery

Artificial Intelligence Versus Manual Planning in Patients Undergoing Robot-assisted Pedicle Screw Internal Fixation: a Prospective Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery
• Intervention / Treatment: Procedure: artificial intelligence based screw planning; Procedure: manually screw planning

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: artificial intelligence planning group	Procedure: artificial intelligence based screw planning; artificial intelligence technology helps to plan screws in robot assisted spinal surgery
Placebo Comparator: manual planning group	Procedure: manually screw planning; the screw trajcetories are manually planned

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy of screw positioning or placement	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The planning time	Time from start to finish of planning	1 day
postoperative complication	Nerve injury, epidural hematoma, and infection	3 month

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 25, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 27, 2024
• First Submitted That Met QC Criteria: May 12, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AI-RASS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No