Navigation and Positioning System for Orthopedic Surgery

A Prospective, Multicenter, Non Inferiority, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Pedicle Screw Fixation Assisted by Orthopedic Surgical Navigation System

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pedicle Screw Fixation of Spine
• Intervention / Treatment: Device: Navigation and Positioning System for Orthopedic Surgeries

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Pan; Phone Number: +86 18916099976; Email: panjing@yijiahe.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. They were 18-75 years old;
2. From thoracic vertebrae to lumbar vertebrae, pedicle screw fixation is needed;
3. Signed informed consent, willing to receive treatment and follow-up according to the requirements of the trial protocol.

Exclusion Criteria:

1. Patients with pedicle deformity.
2. Patients with severe osteoporosis.
3. Patients with spinal tumor or tuberculosis.
4. Patients with abnormal liver function (alanine aminotransferase, aspartate aminotransferase values > 3 times of the upper limit of the normal range) and abnormal renal function (creatinine values > 3 times of the upper limit of the normal range).
5. Patients with abnormal coagulation function (prothrombin time, activated partial thromboplastin time > 1.5 times of the upper limit of normal range).
6. Pregnant or lactating women.
7. Patients with mental disorders.
8. The investigators evaluated patients who were not suitable for pedicle screw fixation.
9. Patients who are participating in clinical trials of any other device or drug.
10. Poor compliance, difficult to cooperate with patients who complete treatment and follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: control group	Device: Navigation and Positioning System for Orthopedic Surgeries; Experimental group: orthopedic surgery navigation system (Tuodao) assisted pedicle screw fixation Control group: orthopedic surgery navigation system (tianzhihang) assisted pedicle screw fixation
EXPERIMENTAL: experimental group	Device: Navigation and Positioning System for Orthopedic Surgeries; Experimental group: orthopedic surgery navigation system (Tuodao) assisted pedicle screw fixation Control group: orthopedic surgery navigation system (tianzhihang) assisted pedicle screw fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Nanjing Tuodao Medical Technology Co., Ltd

Publications and helpful links

General Publications

• 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. Erratum In: Spine (Phila Pa 1976). 2011 Jan 1;36(1):91. Gordon, Donald G [corrected to Donald, Gordon D].
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 28, 2021
• Primary Completion (ANTICIPATED): May 28, 2022
• Study Completion (ANTICIPATED): May 28, 2022

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (ACTUAL): May 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2021-MD-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No