Clinical Trial for the Application of Robotic System in Spinal Surgery

Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03512379
• Other study ID #: JST-201508
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2018
• Source: Beijing Jishuitan Hospital
• Contact: Mingxing Fan, MD,PHD
• Phone: +86-13683360600
• Email: van0208[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Robotic Surgical Procedures
• Safety
• Spinal Surgery

Intervention

Device:
• TIANJI Robot
A robotic system for spinal surgery
• Fluoroscopy
For fluoroscopy-based free hand surgery
• Navigation
For navigation-assisted spinal surgery

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screw guide wire adjustment times	The adjustment times of screw guide wire during surgery	During surgery
Primary	Screw adjustment times	The adjustment times of screw during surgery	During surgery
Primary	Deviation of screw	The deviation between the actual position of screw and the preoperative designed position	Up to 12 weeks
Primary	Perforation rate of screw	Rate of screws breaching out pedicles on postoperative CT image	Up to 12 weeks
Secondary	Operation time	Operation time	During surgery
Secondary	Blood loss	Blood loss during surgery	During surgery
Secondary	Complications	Complications after surgery	Up to 4 weeks
Secondary	Hospital stay after surgery	Hospital stay after surgery	Up to 4 weeks
Secondary	Hospitalization costs	Hospitalization costs	Up to 4 weeks
Secondary	Visual Analogue Scale	Visual Analogue Scale	3 days before surgery
Secondary	Visual Analogue Scale	Visual Analogue Scale	3 days after surgery
Secondary	Neck Disability Index	Neck Disability Index	3 days before surgery
Secondary	Neck Disability Index	Neck Disability Index	3 days after surgery
Secondary	Oswestry Disability Index	Oswestry Disability Index	3 days before surgery
Secondary	Oswestry Disability Index	Oswestry Disability Index	3 days after surgery
Secondary	modified Japanese orthopaedic association score	modified Japanese orthopaedic association score	3 days before surgery
Secondary	modified Japanese orthopaedic association score	modified Japanese orthopaedic association score	3 days after surgery