Clinical Trial for the Application of Tirobot System

Phase 3

Completed

• Conditions: Robotic Surgical Procedures; Fusion of Spine (Disease)
• Interventions: Procedure: free-hand surgery; Procedure: robot-assisted spine surgery; Device: TiRobot system

• Registration Number: NCT02890043
• Lead Sponsor: Beijing Jishuitan Hospital

Brief Summary

The object of this study was to evaluate the accuracy and safety of the Tirobot system.

Detailed Description

Tirobot system is a new-type medical robot-assisted surgery system that designed for spine and traumatic orthopaedic surgeries. This system has been certified by CE. The accuracy and safety of pedicle screw placement using this system will be evaluated.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Study First Submitted: 2016-08-21
• Study First Submitted QC: 2016-08-31
• Status Verified: 2016-09
• Study First Posted: 2016-09-07
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• traumatic or degenerative thoracolumbar disease required for pedicle screw fixation surgery

Exclusion Criteria

• severe osteoporosis
• old thoracolumbar fracture
• deformity of pedicle
• combined with coagulation disorders
• combined with other systematic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free-hand	free-hand surgery	Intervention: Surgery: free-hand surgery
Robot	robot-assisted spine surgery	Intervention: Surgery: robot-assisted spine surgery, device: TiRobot surgery system
Robot	TiRobot system	Intervention: Surgery: robot-assisted spine surgery, device: TiRobot surgery system

Primary Outcome Measures

Name	Time	Method
perforation rate of pedicle screws	up to postoperative 3 days	number of pedicle screws breaching out pedicles on postoperative CT image/ total screw number

Secondary Outcome Measures

Name	Time	Method
operation time	through the operation complete, an average of 2 hours	total operation time of the surgery (time in minutes)
complications	up to postoperative 3 months	Number of Adverse Events That Are Related to Treatments

Trial Locations

Locations (1)

Beijing Jishuitan Hospital; 🇨🇳 Beijing, Beijing, China