## Protocol Section
### Identification Module
**NCT ID:** NCT06416631

**Brief Title:** 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

#### Organization Study ID Info
**ID:** AI-RASS
#### Organization
**Class:** OTHER
**Full Name:** Beijing Jishuitan Hospital
### Status Module
#### Completion Date
**Date:** 2026-05-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-25

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-27
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Jishuitan Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Surgery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: artificial intelligence based screw planning

**Label:** artificial intelligence planning group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Procedure: manually screw planning

**Label:** manual planning group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- artificial intelligence planning group

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

**Name:** artificial intelligence based screw planning

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- manual planning group

**Description:** the screw trajcetories are manually planned

**Name:** manually screw planning

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** The accuracy of screw positioning or placement

**Time Frame:** 1 month

#### Secondary Outcomes

**Description:** Time from start to finish of planning

**Measure:** The planning time

**Time Frame:** 1 day

**Description:** Nerve injury, epidural hematoma, and infection

**Measure:** postoperative complication

**Time Frame:** 3 month

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
