Robotic Surgical Procedures, Spinal Surgery, Safety
Conditions
Keywords
robot-assisted surgery, pedicle screw, spine
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.
Interventions
DEVICETIANJI Robot
A robotic system for spinal surgery
DEVICEFluoroscopy
For fluoroscopy-based free hand surgery
DEVICENavigation
For navigation-assisted spinal surgery
Sponsors
Beijing Jishuitan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Robot-assisted surgery group Free-hand surgery group Navigation-assisted surgery group
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screw guide wire adjustment times | During surgery | The adjustment times of screw guide wire during surgery |
| Screw adjustment times | During surgery | The adjustment times of screw during surgery |
| Deviation of screw | Up to 12 weeks | The deviation between the actual position of screw and the preoperative designed position |
| Perforation rate of screw | Up to 12 weeks | Rate of screws breaching out pedicles on postoperative CT image |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization costs | Up to 4 weeks | Hospitalization costs |
| Visual Analogue Scale | 3 days before surgery | Visual Analogue Scale |
| Operation time | During surgery | Operation time |
| Oswestry Disability Index | 3 days before surgery | Oswestry Disability Index |
| modified Japanese orthopaedic association score | 3 days before surgery | modified Japanese orthopaedic association score |
| Neck Disability Index | 3 days before surgery | Neck Disability Index |
| Blood loss | During surgery | Blood loss during surgery |
| Complications | Up to 4 weeks | Complications after surgery |
| Hospital stay after surgery | Up to 4 weeks | Hospital stay after surgery |
Countries
China
Contacts
Primary ContactMingxing Fan, MD,PHD
Backup ContactYajun Liu, MD,PHD
Outcome results
None listed