Fusion of Spine (Disease), Robotic Surgical Procedures
Conditions
Keywords
spine, robot-assisted surgery, pedicle screw
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.
Interventions
PROCEDURErobot-assisted spine surgery
robot-assisted spine surgery using Tirobot system
PROCEDUREfree-hand surgery
traditional free-hand surgery
DEVICETiRobot system
a robot-assisted spine surgery system
Sponsors
Beijing Tinavi Medical Technology Co Ltd
Chinese PLA General Hospital
Tianjin Hospital
Beijing Jishuitan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed