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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot assisted surgery group | Experimental | Spinal surgery using TIANJI Robot system. |
|
| Free hand surgery group | Active Comparator | Spinal surgery using fluoroscopy-based free hand technique |
|
| Navigation-assisted surgery group | Active Comparator | Spinal surgery using Navigation-assisted technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIANJI Robot | Device | A robotic system for spinal surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Screw guide wire adjustment times | The adjustment times of screw guide wire during surgery | During surgery |
| Screw adjustment times | The adjustment times of screw during surgery | During surgery |
| Deviation of screw | The deviation between the actual position of screw and the preoperative designed position | Up to 12 weeks |
| Perforation rate of screw | Rate of screws breaching out pedicles on postoperative CT image | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | Operation time | During surgery |
| Blood loss | Blood loss during surgery | During surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingxing Fan, MD,PHD | Contact | +86-13683360600 | van0208@163.com | |
| Yajun Liu, MD,PHD | Contact | +86-13911878647 | drliuyajun@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Tian, MD,PHD | Beijing Jishuitan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Jishuitan Hospital | Recruiting | Beijing | Beijing Municipality | 100035 | China |
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| ID | Term |
|---|---|
| D005471 | Fluoroscopy |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Robot-assisted surgery group Free-hand surgery group Navigation-assisted surgery group
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| Fluoroscopy |
| Device |
For fluoroscopy-based free hand surgery |
|
| Navigation | Device | For navigation-assisted spinal surgery |
|
| Complications | Complications after surgery | Up to 4 weeks |
| Hospital stay after surgery | Hospital stay after surgery | Up to 4 weeks |
| Hospitalization costs | Hospitalization costs | Up to 4 weeks |
| Visual Analogue Scale | Visual Analogue Scale | 3 days before surgery |
| Visual Analogue Scale | Visual Analogue Scale | 3 days after surgery |
| Neck Disability Index | Neck Disability Index | 3 days before surgery |
| Neck Disability Index | Neck Disability Index | 3 days after surgery |
| Oswestry Disability Index | Oswestry Disability Index | 3 days before surgery |
| Oswestry Disability Index | Oswestry Disability Index | 3 days after surgery |
| modified Japanese orthopaedic association score | modified Japanese orthopaedic association score | 3 days before surgery |
| modified Japanese orthopaedic association score | modified Japanese orthopaedic association score | 3 days after surgery |