Navigation and Positioning System for Orthopedic Surgery

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Pedicle Screw Fixation of Spine

Intervention / Treatment
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* Device: Navigation and Positioning System for Orthopedic Surgeries


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: NS100
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br> | Device: Navigation and Positioning System for Orthopedic Surgeries<br>* Experimental group: orthopedic surgery navigation system (Tuodao) assisted pedicle screw fixation Control group: orthopedic surgery navigation system (tianzhihang) assisted pedicle screw fixation<br>|
| Active Comparator: control group<br> | Device: Navigation and Positioning System for Orthopedic Surgeries<br>* Experimental group: orthopedic surgery navigation system (Tuodao) assisted pedicle screw fixation Control group: orthopedic surgery navigation system (tianzhihang) assisted pedicle screw fixation<br>|

What is the study measuring?
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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 |