Clinical Trial for the Application of Robotic System in Spinal Surgery

Not Applicable

• Conditions: Safety; Spinal Surgery; Robotic Surgical Procedures
• Interventions: Device: Fluoroscopy; Device: Navigation; Device: TIANJI Robot

• Registration Number: NCT03512379
• Lead Sponsor: Beijing Jishuitan Hospital

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.

Study Timeline

• Study Start: 2015-08-01
• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-04-30
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-09-24
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free hand surgery group	Fluoroscopy	Spinal surgery using fluoroscopy-based free hand technique
Navigation-assisted surgery group	Navigation	Spinal surgery using Navigation-assisted technique
Robot assisted surgery group	TIANJI Robot	Spinal surgery using TIANJI Robot system.

Primary Outcome Measures

Name	Time	Method
Screw guide wire adjustment times	During surgery	The adjustment times of screw guide wire during surgery
Perforation rate of screw	Up to 12 weeks	Rate of screws breaching out pedicles on postoperative CT image
Screw adjustment times	During surgery	The adjustment times of screw during surgery
Deviation of screw	Up to 12 weeks	The deviation between the actual position of screw and the preoperative designed position

Secondary Outcome Measures

Name	Time	Method
Operation time	During surgery	Operation time
Blood loss	During surgery	Blood loss during surgery
Complications	Up to 4 weeks	Complications after surgery
Hospital stay after surgery	Up to 4 weeks	Hospital stay after surgery
Hospitalization costs	Up to 4 weeks	Hospitalization costs
Visual Analogue Scale	3 days after surgery	Visual Analogue Scale
Neck Disability Index	3 days after surgery	Neck Disability Index
Oswestry Disability Index	3 days after surgery	Oswestry Disability Index
modified Japanese orthopaedic association score	3 days after surgery	modified Japanese orthopaedic association score

Trial Locations

Locations (1)

Beijing Jishuitan Hospital; 🇨🇳 Beijing, Beijing, China