## Protocol Section
### Identification Module
**NCT ID:** NCT03512379

**Brief Title:** Clinical Trial for the Application of Robotic System in Spinal Surgery

**Official Title:** Clinical Trial for the Application of Robotic System in Spinal Surgery: a Randomized Controlled Study

#### Organization Study ID Info
**ID:** JST-201508
#### Organization
**Class:** OTHER
**Full Name:** Beijing Jishuitan Hospital
### Status Module
#### Completion Date
**Date:** 2021-12-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2018-09-24

**Type:** ACTUAL

**Last Update Submit Date:** 2018-09-20

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-08-01

**Type:** ACTUAL

**Status Verified Date:** 2018-09

#### Study First Post Date
**Date:** 2018-04-30
**Type:** ACTUAL
**Study First Submit Date:** 2018-04-03
**Study First Submit QC Date:** 2018-04-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Jishuitan Hospital

#### Responsible Party

**Investigator Affiliation:** Beijing Jishuitan Hospital

**Investigator Full Name:** Wei Tian

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.

**Detailed Description:** Robot assisted operation is new for spinal surgery, in this study, we will evaluate the accuracy, safety and clinical outcomes compared with traditional free hand operation and navigation assisted operation.

### Conditions Module

**Conditions:**

- Robotic Surgical Procedures

- Spinal Surgery

- Safety

**Keywords:**

- robot-assisted surgery

- pedicle screw

- spine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Robot-assisted surgery group Free-hand surgery group Navigation-assisted surgery group

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Spinal surgery using TIANJI Robot system.

**Intervention Names:**

- Device: TIANJI Robot

**Label:** Robot assisted surgery group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Spinal surgery using fluoroscopy-based free hand technique

**Intervention Names:**

- Device: Fluoroscopy

**Label:** Free hand surgery group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Spinal surgery using Navigation-assisted technique

**Intervention Names:**

- Device: Navigation

**Label:** Navigation-assisted surgery group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Robot assisted surgery group

**Description:** A robotic system for spinal surgery

**Name:** TIANJI Robot

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Free hand surgery group

**Description:** For fluoroscopy-based free hand surgery

**Name:** Fluoroscopy

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- Navigation-assisted surgery group

**Description:** For navigation-assisted spinal surgery

**Name:** Navigation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The adjustment times of screw guide wire during surgery

**Measure:** Screw guide wire adjustment times

**Time Frame:** During surgery

**Description:** The adjustment times of screw during surgery

**Measure:** Screw adjustment times

**Time Frame:** During surgery

**Description:** The deviation between the actual position of screw and the preoperative designed position

**Measure:** Deviation of screw

**Time Frame:** Up to 12 weeks

**Description:** Rate of screws breaching out pedicles on postoperative CT image

**Measure:** Perforation rate of screw

**Time Frame:** Up to 12 weeks

#### Secondary Outcomes

**Description:** Operation time

**Measure:** Operation time

**Time Frame:** During surgery

**Description:** Blood loss during surgery

**Measure:** Blood loss

**Time Frame:** During surgery

**Description:** Complications after surgery

**Measure:** Complications

**Time Frame:** Up to 4 weeks

**Description:** Hospital stay after surgery

**Measure:** Hospital stay after surgery

**Time Frame:** Up to 4 weeks

**Description:** Hospitalization costs

**Measure:** Hospitalization costs

**Time Frame:** Up to 4 weeks

**Description:** Visual Analogue Scale

**Measure:** Visual Analogue Scale

**Time Frame:** 3 days before surgery

**Description:** Visual Analogue Scale

**Measure:** Visual Analogue Scale

**Time Frame:** 3 days after surgery

**Description:** Neck Disability Index

**Measure:** Neck Disability Index

**Time Frame:** 3 days before surgery

**Description:** Neck Disability Index

**Measure:** Neck Disability Index

**Time Frame:** 3 days after surgery

**Description:** Oswestry Disability Index

**Measure:** Oswestry Disability Index

**Time Frame:** 3 days before surgery

**Description:** Oswestry Disability Index

**Measure:** Oswestry Disability Index

**Time Frame:** 3 days after surgery

**Description:** modified Japanese orthopaedic association score

**Measure:** modified Japanese orthopaedic association score

**Time Frame:** 3 days before surgery

**Description:** modified Japanese orthopaedic association score

**Measure:** modified Japanese orthopaedic association score

**Time Frame:** 3 days after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Spinal disease required for screw fixation；signed the inform consent

Exclusion Criteria:

* Patients with severe osteoporosis; patients with old fractures; patients with pedicle deformity; patients with severe systemic diseases; patients with coagulation disorders; patients who are considered unsuitable for this trail by the clinician.

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** van0208@163.com

**Name:** Mingxing Fan, MD,PHD

**Phone:** +86-13683360600

**Role:** CONTACT

**Contact 2:**

**Email:** drliuyajun@163.com

**Name:** Yajun Liu, MD,PHD

**Phone:** +86-13911878647

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** zhangweijun@tinavi.com

- **Name:** Weijun Zhang, MD

- **Phone:** 010-82156660

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Jishuitan Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100035

#### Overall Officials

**Official 1:**

**Affiliation:** Beijing Jishuitan Hospital

**Name:** Wei Tian, MD,PHD

**Role:** STUDY_CHAIR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
