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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Anatase" Spine Surgery Navigation System | Experimental | Using "Anatase" Spine Surgery Navigation System in pedicle screw placement in spine surgery |
|
| Medtronic Stealthstation S7 Treatment Guidance System | Active Comparator | Using Medtronic Stealthstation S7 Treatment Guidance System in pedicle screw placement in spine surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Anatase" Spine Surgery Navigation System | Device | using navigation system in pedicle screw placement in spine surgery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsung-Hsi Tu | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taiwan |
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| Medtronic Stealthstation S7 Treatment Guidance System | Device | using navigation system in pedicle screw placement in spine surgery |
|
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 |
| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| D013124 | Spinal Injuries |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
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