Navigation and Positioning System for Orthopedic Surgery

NCT04883580 | Unknown

• 1 other identifier: 2021-MD-100
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pedicle Screw Fixation of Spine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Excellent and good rate of pedicle screw placement

  Discharge or 7 days after surgery, whichever comes first

• Entry point deviation

  Immediately after operation

• Dead center deviation

  Immediately after operation

• Angle deviation of axial plane

  Immediately after operation

• Angular deviation of sagittal plane

  Immediately after operation

Study Arms (2)

experimental group

EXPERIMENTAL

Device: Navigation and Positioning System for Orthopedic Surgeries

control group

ACTIVE COMPARATOR

Device: Navigation and Positioning System for Orthopedic Surgeries

Interventions

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

control group; experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with pedicle deformity.
• Patients with severe osteoporosis.
• Patients with spinal tumor or tuberculosis.
• 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).
• Patients with abnormal coagulation function (prothrombin time, activated partial thromboplastin time \> 1.5 times of the upper limit of normal range).
• Pregnant or lactating women.
• Patients with mental disorders.
• The investigators evaluated patients who were not suitable for pedicle screw fixation.
• Patients who are participating in clinical trials of any other device or drug.
• Poor compliance, difficult to cooperate with patients who complete treatment and follow-up.

Sponsors & Collaborators

• Nanjing Tuodao Medical Technology Co., Ltd: lead

Related Publications (12)

• 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.

  PMID: 22987158 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.

  PMID: 20862593 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.

  PMID: 21079498 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.

  PMID: 17556141 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.

  PMID: 14563154 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.

  PMID: 17268254 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.

  PMID: 11927817 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.

  PMID: 14673715 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.

  PMID: 10905443 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.

  PMID: 12897475 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.

  PMID: 26686604 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.

  PMID: 28463620 RESULT

MeSH Terms

Interventions

Orthopedic Procedures

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Jing Pan

CONTACT

+86 18916099976; panjing@yijiahe.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: NS100

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: May 28, 2021
• Primary Completion: May 28, 2022
• Study Completion: May 28, 2022
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share