Clinical Trial for the Application of Robotic System in Spinal Surgery: a Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Robotic Surgical Procedures
- Sponsor
- Beijing Jishuitan Hospital
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Screw guide wire adjustment times
- Last Updated
- 7 years ago
Overview
Brief Summary
This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.
Detailed 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.
Investigators
Wei Tian
Professor
Beijing Jishuitan Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Screw guide wire adjustment times
Time Frame: During surgery
The adjustment times of screw guide wire during surgery
Perforation rate of screw
Time Frame: Up to 12 weeks
Rate of screws breaching out pedicles on postoperative CT image
Screw adjustment times
Time Frame: During surgery
The adjustment times of screw during surgery
Deviation of screw
Time Frame: Up to 12 weeks
The deviation between the actual position of screw and the preoperative designed position
Secondary Outcomes
- Operation time(During surgery)
- Blood loss(During surgery)
- Complications(Up to 4 weeks)
- Hospital stay after surgery(Up to 4 weeks)
- Hospitalization costs(Up to 4 weeks)
- Visual Analogue Scale(3 days after surgery)
- Neck Disability Index(3 days after surgery)
- Oswestry Disability Index(3 days after surgery)
- modified Japanese orthopaedic association score(3 days after surgery)