Clinical trial NCT06416631: Artificial Intelligence Versus Maunal Planning in Robot Assisted Spinal Surgery
Official title: Artificial Intelligence Versus Manual Planning in Patients Undergoing Robot-assisted Pedicle Screw Internal Fixation: a Prospective Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgery
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The accuracy of screw positioning or placement
timeFrame: 1 month
Secondary outcomes:
measure: The planning time
timeFrame: 1 day
measure: postoperative complication
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
References: