An interventional study of TIANJI Robot and Fluoroscopy in Robotic Surgical Procedures, Spinal Surgery and Safety, sponsored by Beijing Jishuitan Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-09-24.
Sponsored by Beijing Jishuitan Hospital · Not applicable, Interventional, and Treatment
This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.
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.
Beijing Jishuitan Hospital is the lead sponsor of 43 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Spinal surgery using TIANJI Robot system.
Device: TIANJI Robot
Spinal surgery using fluoroscopy-based free hand technique
Device: Fluoroscopy
Spinal surgery using Navigation-assisted technique
Device: Navigation
A robotic system for spinal surgery
For fluoroscopy-based free hand surgery
For navigation-assisted spinal surgery
Screw guide wire adjustment times
The adjustment times of screw guide wire during surgery
Time frame: During surgery
Screw adjustment times
The adjustment times of screw during surgery
Time frame: During surgery
Deviation of screw
The deviation between the actual position of screw and the preoperative designed position
Time frame: Up to 12 weeks
Perforation rate of screw
Rate of screws breaching out pedicles on postoperative CT image
Time frame: Up to 12 weeks
Operation time
Operation time
Time frame: During surgery
Blood loss
Blood loss during surgery
Time frame: During surgery
Complications
Complications after surgery
Time frame: Up to 4 weeks
Hospital stay after surgery
Hospital stay after surgery
Time frame: Up to 4 weeks
Hospitalization costs
Hospitalization costs
Time frame: Up to 4 weeks
Visual Analogue Scale
Visual Analogue Scale
Time frame: 3 days before surgery
Visual Analogue Scale
Visual Analogue Scale
Time frame: 3 days after surgery
Neck Disability Index
Neck Disability Index
Time frame: 3 days before surgery
Neck Disability Index
Neck Disability Index
Time frame: 3 days after surgery
Oswestry Disability Index
Oswestry Disability Index
Time frame: 3 days before surgery
Oswestry Disability Index
Oswestry Disability Index
Time frame: 3 days after surgery
modified Japanese orthopaedic association score
modified Japanese orthopaedic association score
Time frame: 3 days before surgery
modified Japanese orthopaedic association score
modified Japanese orthopaedic association score
Time frame: 3 days after surgery
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Beijing Jishuitan Hospital