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| Name | Class |
|---|---|
| Beijing Tinavi Medical Technology Co Ltd | UNKNOWN |
| Chinese PLA General Hospital | OTHER |
| Tianjin Hospital | OTHER |
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The object of this study was to evaluate the accuracy and safety of the Tirobot system.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot | Experimental | Intervention: Surgery: robot-assisted spine surgery, device: TiRobot surgery system |
|
| Free-hand | Active Comparator | Intervention: Surgery: free-hand surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robot-assisted spine surgery | Procedure | robot-assisted spine surgery using Tirobot system |
| |
| Measure | Description | Time Frame |
|---|---|---|
| perforation rate of pedicle screws | number of pedicle screws breaching out pedicles on postoperative CT image/ total screw number | up to postoperative 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| operation time | total operation time of the surgery (time in minutes) | through the operation complete, an average of 2 hours |
| complications | Number of Adverse Events That Are Related to Treatments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Tian, MD | Beijing Jishuitan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Jishuitan Hospital | Beijing | Beijing Municipality | 100035 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21079498 | Result | Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab. | |
| 18418139 |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| free-hand surgery |
| Procedure |
traditional free-hand surgery |
|
| TiRobot system | Device | a robot-assisted spine surgery system |
|
| up to postoperative 3 months |
| Result |
| Karapinar L, Erel N, Ozturk H, Altay T, Kaya A. Pedicle screw placement with a free hand technique in thoracolumbar spine: is it safe? J Spinal Disord Tech. 2008 Feb;21(1):63-7. doi: 10.1097/BSD.0b013e3181453dc6. |
| 1395312 | Result | Weinstein JN, Rydevik BL, Rauschning W. Anatomic and technical considerations of pedicle screw fixation. Clin Orthop Relat Res. 1992 Nov;(284):34-46. |
| 30738398 | Derived | Han X, Tian W, Liu Y, Liu B, He D, Sun Y, Han X, Fan M, Zhao J, Xu Y, Zhang Q. Safety and accuracy of robot-assisted versus fluoroscopy-assisted pedicle screw insertion in thoracolumbar spinal surgery: a prospective randomized controlled trial. J Neurosurg Spine. 2019 Feb 8;30(5):615-622. doi: 10.3171/2018.10.SPINE18487. Print 2019 May 1. |