Artificial Intelligence Versus Maunal Planning in Robot Assisted Spinal Surgery

Launched by BEIJING JISHUITAN HOSPITAL · May 12, 2024

Keywords

ClinConnect Summary

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 g...

Gender

ALL

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.