Artificial Intelligence Versus Maunal Planning in Robot Assisted Spinal Surgery

NCT06416631 | Not Yet Recruiting

• 1 other identifier: AI-RASS
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The planning time

  1 day

• postoperative complication

  3 month

Study Arms (2)

artificial intelligence planning group

EXPERIMENTAL

Procedure: artificial intelligence based screw planning

manual planning group

PLACEBO COMPARATOR

Procedure: manually screw planning

Interventions

artificial intelligence based screw planning PROCEDURE

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

artificial intelligence planning group

manually screw planning PROCEDURE

the screw trajcetories are manually planned

manual planning group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 16, 2024
• Study Start: May 25, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-04