Clinical Trial for the Application of Tirobot System

Beijing Jishuitan Hospital88 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Fusion of Spine (Disease)Robotic Surgical Procedures

Interventions

robot-assisted spine surgeryPROCEDURE

robot-assisted spine surgery using Tirobot system

free-hand surgeryPROCEDURE

traditional free-hand surgery

TiRobot systemDEVICE

a robot-assisted spine surgery system

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

perforation rate of pedicle screws

number of pedicle screws breaching out pedicles on postoperative CT image/ total screw number

Time frame: up to postoperative 3 days

Secondary Outcomes

operation time

total operation time of the surgery (time in minutes)

Time frame: through the operation complete, an average of 2 hours

complications

Number of Adverse Events That Are Related to Treatments

Time frame: up to postoperative 3 months

Data from ClinicalTrials.gov

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