Study to Evaluate the Safety and Clinical Outcome of Using Navigation System in Pedicle Screw Placement in Spine Surgery

Study Overview
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Brief Summary
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The research project is testing whether in screw insertion of spine surgery using Anatase Spine Surgery Navigation System is at least as safe and accurate as using O-arm assisted spine surgery- Medtronic Stealthstation S7 Treatment Guidance System.

Detailed Description
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Pedicle screw insertion is performed to treat the patients with spine conditions, including degenerative, traumatogenic, and neoplastic lesions. Accurate insertion of pedicle screw is a crucial step which directly affects the surgical outcomes. In order to place the screws safely and accurately, various conventional techniques have been used, focusing on marking anatomical locations, entry points and insertion angles. Since the early 1990, the methods using computer systems that allow real-time image processing have been explored in order to improve the accuracy of pedicle screw placement. The Medtronic StealthStation® S7® System is a hardware platform that enables real-time surgical navigation using radiological patient images. The application software reformats patient-specific CT or MR images acquired before surgery, or fluoroscopic images acquired during surgery, and displays them on-screen from a variety of perspectives. The Anatase Spine Surgery Navigation System is indicated for precisely positioning of surgical instruments and/or implants during general spinal surgery, such as pedicle screw placement. This study will be a two-arms, single center, evaluator blind, controlled, parallel, randomised study in patients with pedicle screw placement in spine surgery. This trial will include patients need to undergo pedicle screw placement surgery with indication of spinal tumor, traumatic injury or degenerative spine disease (Pedicle screws placed from 10th thoracic vertebra to first sacrum), who are ≥20 years and ≤80 years of age with Body Mass Index (BMI) < 40 kg/m2 and Spine T-Score ≥ -2.5.

Official Title
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A Two-arm, Single Center, Randomised Study to Evaluate the Safety and Clinical Outcome of Using Navigation System in Pedicle Screw Placement in Spine Surgery

Conditions
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Spinal Tumor, Traumatic Injury of Spine, Degenerative Spine Disease

Intervention / Treatment
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* Device: Anatase Spine Surgery Navigation System
* Device: Medtronic Stealthstation S7 Treatment Guidance System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who need to undergo pedicle screw placement surgery with indication of spinal tumor, traumatic injury or degenerative spine disease. Pedicle screws placed from 10th thoracic vertebra to first sacrum. Age ≥20 years and ≤80 years. Body Mass Index (BMI) < 40 kg/m2. Spine T-Score by Dual Energy X-ray Absorptiometry ≥ -2.5, 60 days prior to surgery. The subject is willing and able to comply with the procedure and requirements of this trial. The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements. Exclusion Criteria: Pregnant women. Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency. Be on uncontrolled Diabetes mellitus. Any history of stroke within the previous 6 months. Any history or current evidence suggestive of Coronary Artery Disease or Cerebral Vascular Accident within the previous 6 months, including clinical, EKG, laboratory, or imaging findings. Any terminal illness such that the patient would not be expected to survive more than 6 months. Creutzfeldt-Jakob disease. Known allergy to stainless steel (device material). Have a systematic or local infection, which may increase study risk. Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia. Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months. Any condition that, in the judgment of the investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. Former spinal surgery may interfere with the present trial. Participation in any investigational study in the last 30 days or current enrolment in any trial. Non- interventional Studies are not considered exclusion. Any condition that increases anesthesia risk.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anatase Spine Surgery Navigation System<br>Using Anatase Spine Surgery Navigation System in pedicle screw placement in spine surgery | Device: Anatase Spine Surgery Navigation System<br>* using navigation system in pedicle screw placement in spine surgery<br>|
| Active Comparator: Medtronic Stealthstation S7 Treatment Guidance System<br>Using Medtronic Stealthstation S7 Treatment Guidance System in pedicle screw placement in spine surgery | Device: Medtronic Stealthstation S7 Treatment Guidance System<br>* using navigation system in pedicle screw placement in spine surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of screw outside the vertebral body | Rate of screw outside the vertebral body as measure by post CT image which perform not later than discharge. | not later than discharge, up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the actual and virtual (navigation image) of screw's sharp point position | Blind Assessor will measure the distance (mm) between the actual (post-CT) and virtual (baseline CT) of screw's sharp point position. | not later than discharge, up to 14 days | 
| Difference between the actual and virtual (navigation image) angle of screws | Blind Assessor will measure the difference of angle (°) between the actual (post-CT) and virtual (baseline CT)screws. | not later than discharge, up to 14 days | 
| Blood loss during surgery (mL) | record the blood loss during surgery (mL) | operation 1 day | 
| Total intraoperative radiation exposure for the operator and patient | Record the total intraoperative radiation exposure of operator and patient wearing TLD badges | 1 day, the TLD badges will be detected | 
| Mean time required for preparation of screw placement (min) | Record the mean time required for preparation of screw placement (min) | operation 1 day | 
| Time to accomplish each screw insertion (min) | Record the time to accomplish each screw insertion (min) | operation 1 day | 
| Ratio of revision surgery within 3 months after main surgery | Record ration of revision surgery within 3 months after main surgery | after 3 months of surgery | 
| Length of postoperative hospital stay | Record length of postoperative hospital stay | Discharge day, up to 14 days | 
| Adverse event (AE) and serious AE (SAE) incidence rates during the trial | Record Adverse event (AE) and serious AE (SAE) during the trial | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pedicle screw placement surgery, 10th thoracic vertebra to 1st sacrum