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Pedicle Screw Fixation of SpineNCT04883580

Navigation and Positioning System for Orthopedic Surgery

A study testing Navigation and Positioning System for Orthopedic Surgeries in people with Pedicle Screw Fixation of Spine, run by Nanjing Tuodao Medical Technology Co., Ltd.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pedicle Screw Fixation of Spine
What is being tested?
Navigation and Positioning System for Orthopedic Surgeries
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
No sites listed yet
Study dates
28 May 2021to 28 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet.

Jing Pan contact

+86 18916099976

panjing@yijiahe.com

About this study

Official title: 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

Being tested
Navigation and Positioning System for Orthopedic Surgeries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Navigation and Positioning System for Orthopedic SurgeriesDevice

    Experimental group: orthopedic surgery navigation system (Tuodao) assisted pedicle screw fixation

    Control group: orthopedic surgery navigation system (tianzhihang) assisted pedicle screw fixation

Study groups in NCT04883580
Study groupRoleWhat they receive
experimental groupExperimentalNot described
Receives: Device: Navigation and Positioning System for Orthopedic Surgeries
control groupActive comparatorNot described
Receives: Device: Navigation and Positioning System for Orthopedic Surgeries

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Immediately after operation

Secondary outcomes (15)

  1. 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)

    Measured: Discharge or 7 days after surgery, whichever comes first

  2. 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

    Measured: Immediately after operation

  3. 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

    Measured: Immediately after operation

  4. 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

    Measured: Immediately after operation

  5. 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

    Measured: Immediately after operation

  6. Spatial angle deviation

    The minimum angle between the planned position of the passage and the actual position of the Kirschner wire in space

    Measured: Immediately after operation

  7. 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

    Measured: Immediately after operation

  8. Incidence of re nailing

    Measured: Immediately after operation

  9. Incidence of conversion to manual nail placement

    Measured: Immediately after operation

  10. 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

    Measured: Immediately after operation

  11. 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

    Measured: Immediately after operation

  12. Success rate of operation

    The success of operation refers to the success of instruments and techniques in the operation without serious complications

    Measured: Immediately after operation

  13. 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

    Measured: Immediately after operation

  14. Incidence of severe surgical complications

    Severe complications included nerve root injury, vascular injury, spinal cord injury, visceral injury and pedicle fracture

    Measured: Discharge or 7 days after surgery, whichever comes first

  15. Incidence of adverse events and serious adverse events

    Measured: Discharge or 7 days after surgery, whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2021
  2. Study start28 May 2021 (estimated)
  3. Primary completion28 May 2022 (estimated)
  4. Study completion28 May 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
NS100
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04883580
Sponsor's protocol ID
2021-MD-100
Status last verified
May 2021
First submitted
7 May 2021
Last updated
12 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22987158

  • 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.

    PubMed 20862593

  • 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.

    PubMed 21079498

  • 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.

    PubMed 17556141

  • 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.

    PubMed 14563154

  • 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.

    PubMed 17268254

  • 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.

    PubMed 11927817

  • 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.

    PubMed 14673715

  • 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.

    PubMed 10905443

  • 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.

    PubMed 12897475

  • 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.

    PubMed 26686604

  • 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.

    PubMed 28463620

Questions about this trial

What is this clinical trial studying?

A study testing Navigation and Positioning System for Orthopedic Surgeries in people with Pedicle Screw Fixation of Spine, run by Nanjing Tuodao Medical Technology Co., Ltd.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jing Pan (+86 18916099976, panjing@yijiahe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Deviation of the position of Kirschner needle (time frame: Immediately after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04883580, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.

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