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This clinical trial is a prospective, multicenter, non inferiority, randomized controlled trial. We plan to include 112 subjects in China and randomly assign them to the experimental group and the control group according to the ratio of 1:1. The experimental group used the orthopedic surgery navigation and positioning system produced by Nanjing Tuodao Medical Technology Co., Ltd., while the control group used the orthopedic surgery navigation and positioning system produced by Beijing tianzhihang Medical Technology Co., Ltd. Taking the position deviation of Kirschner wire as the main evaluation index, it was proved that the test instrument was not inferior to the control instrument. The test data shall be submitted to the State Drug Administration for approval of the marketing license of the test device
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental |
| |
| control group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigation and Positioning System for Orthopedic Surgeries | Device | Experimental group: orthopedic surgery navigation system (Tuodao) assisted pedicle screw fixation Control group: orthopedic surgery navigation system (tianzhihang) assisted pedicle screw fixation |
| Measure | Description | Time Frame |
|---|---|---|
| Deviation of the position of Kirschner needle | Comparing the actual placement position of Kirschner wire with the planned position of C-arm 3D scanning, the average deviation of the entry point and the insertion point was the position deviation of Kirschner wire | Immediately after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Excellent and good rate of pedicle screw placement | Gertzbein Robbins classification criteria: whether there is cortical penetration in the lateral, medial, cephalic and caudal directions of pedicle screws (A: no cortical invasion; B: no cortical invasion); B: Cortical penetration was less than 2 mm; C: 2mm ≤ cortical penetration < 4mm; D: 4mm ≤ 6 mm; E: Cortical penetration ≥ 6 mm) | Discharge or 7 days after surgery, whichever comes first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Pan | Contact | +86 18916099976 | panjing@yijiahe.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22987158 | Result | Tian W, Liu Y, Zheng S, Lv Y. Accuracy of lower cervical pedicle screw placement with assistance of distinct navigation systems: a human cadaveric study. Eur Spine J. 2013 Jan;22(1):148-55. doi: 10.1007/s00586-012-2494-6. Epub 2012 Sep 18. | |
| 20862593 | Result | Tian NF, Huang QS, Zhou P, Zhou Y, Wu RK, Lou Y, Xu HZ. Pedicle screw insertion accuracy with different assisted methods: a systematic review and meta-analysis of comparative studies. Eur Spine J. 2011 Jun;20(6):846-59. doi: 10.1007/s00586-010-1577-5. Epub 2010 Sep 23. |
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| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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NS100
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| Entry point deviation | The space distance between the entrance point of the planned position of the passage and the axis of the actual placement position of the Kirschner wire | Immediately after operation |
| Dead center deviation | The space distance between the end point of the planned position of the passage and the axis of the actual placement position of the Kirschner wire | Immediately after operation |
| Angle deviation of axial plane | The minimum angle between the planned position of the passage and the projection position of the Kirschner wire on the axial plane | Immediately after operation |
| Angular deviation of sagittal plane | The minimum angle between the planned position of the passage and the projection position of the Kirschner wire on the sagittal plane | Immediately after operation |
| Spatial angle deviation | The minimum angle between the planned position of the passage and the actual position of the Kirschner wire in space | Immediately after operation |
| Operation time | The time from the beginning of registration to the end of the nail placement in the navigation and positioning system of orthopedic surgery | Immediately after operation |
| Incidence of re nailing | Immediately after operation |
| Incidence of conversion to manual nail placement | Immediately after operation |
| apparatus Success rate | Instrument success refers to that during the operation, the operator completes the operation channel planning based on the three-dimensional scanning image data of the C-arm, and the orthopedic surgery navigation and positioning system makes the manipulator move to the position specified in the operation planning under the monitoring of the operator, without instrument defects | Immediately after operation |
| Technical success rate | Technical success refers to the successful insertion of Kirschner wire along the guider and sleeve during the operation without re insertion or changing to manual insertion | Immediately after operation |
| Success rate of operation | The success of operation refers to the success of instruments and techniques in the operation without serious complications | Immediately after operation |
| Incidence of device defects | Device defect refers to the unreasonable risk of medical devices that may endanger human health and life safety in normal use, such as label error, quality problem, fault, etc | Immediately after operation |
| Incidence of severe surgical complications | Severe complications included nerve root injury, vascular injury, spinal cord injury, visceral injury and pedicle fracture | Discharge or 7 days after surgery, whichever comes first |
| Incidence of adverse events and serious adverse events | Discharge or 7 days after surgery, whichever comes first |
| 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. |
| 17556141 | Result | Burch S. Surgical complications of spinal deformity surgery. Neurosurg Clin N Am. 2007 Apr;18(2):385-92. doi: 10.1016/j.nec.2007.02.007. |
| 14563154 | Result | Holly LT, Foley KT. Three-dimensional fluoroscopy-guided percutaneous thoracolumbar pedicle screw placement. Technical note. J Neurosurg. 2003 Oct;99(3 Suppl):324-9. doi: 10.3171/spi.2003.99.3.0324. |
| 17268254 | Result | Kosmopoulos V, Schizas C. Pedicle screw placement accuracy: a meta-analysis. Spine (Phila Pa 1976). 2007 Feb 1;32(3):E111-20. doi: 10.1097/01.brs.0000254048.79024.8b. |
| 11927817 | Result | Klein SA, Glassman SD, Dimar JR 2nd, Voor MJ. Evaluation of the fixation and strength of a "rescue" revision pedicle screw. J Spinal Disord Tech. 2002 Apr;15(2):100-4. doi: 10.1097/00024720-200204000-00002. |
| 14673715 | Result | Tan SH, Teo EC, Chua HC. Quantitative three-dimensional anatomy of cervical, thoracic and lumbar vertebrae of Chinese Singaporeans. Eur Spine J. 2004 Mar;13(2):137-46. doi: 10.1007/s00586-003-0586-z. Epub 2003 Dec 12. |
| 10905443 | Result | Laine T, Lund T, Ylikoski M, Lohikoski J, Schlenzka D. Accuracy of pedicle screw insertion with and without computer assistance: a randomised controlled clinical study in 100 consecutive patients. Eur Spine J. 2000 Jun;9(3):235-40. doi: 10.1007/s005860000146. |
| 12897475 | Result | Holly LT, Foley KT. Intraoperative spinal navigation. Spine (Phila Pa 1976). 2003 Aug 1;28(15 Suppl):S54-61. doi: 10.1097/01.BRS.0000076899.78522.D9. |
| 26686604 | Result | Mendelsohn D, Strelzow J, Dea N, Ford NL, Batke J, Pennington A, Yang K, Ailon T, Boyd M, Dvorak M, Kwon B, Paquette S, Fisher C, Street J. Patient and surgeon radiation exposure during spinal instrumentation using intraoperative computed tomography-based navigation. Spine J. 2016 Mar;16(3):343-54. doi: 10.1016/j.spinee.2015.11.020. Epub 2015 Dec 10. |
| 28463620 | Result | Solomiichuk V, Fleischhammer J, Molliqaj G, Warda J, Alaid A, von Eckardstein K, Schaller K, Tessitore E, Rohde V, Schatlo B. Robotic versus fluoroscopy-guided pedicle screw insertion for metastatic spinal disease: a matched-cohort comparison. Neurosurg Focus. 2017 May;42(5):E13. doi: 10.3171/2017.3.FOCUS1710. |