Surgery
Conditions
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.
Interventions
PROCEDUREartificial intelligence based screw planning
artificial intelligence technology helps to plan screws in robot assisted spinal surgery
PROCEDUREmanually screw planning
the screw trajcetories are manually planned
Sponsors
Beijing Jishuitan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The planning time | 1 day | Time from start to finish of planning |
| postoperative complication | 3 month | Nerve injury, epidural hematoma, and infection |
Outcome results
None listed