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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
55
using navigation system in pedicle screw placement in spine surgery
using navigation system in pedicle screw placement in spine surgery
Taipei Veterans General Hospital
Taipei, Taiwan
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.
Time frame: not later than discharge, up to 14 days
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.
Time frame: 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.
Time frame: not later than discharge, up to 14 days
Blood loss during surgery (mL)
record the blood loss during surgery (mL)
Time frame: 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
Time frame: 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)
Time frame: operation 1 day
Time to accomplish each screw insertion (min)
Record the time to accomplish each screw insertion (min)
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Time frame: operation 1 day
Ratio of revision surgery within 3 months after main surgery
Record ration of revision surgery within 3 months after main surgery
Time frame: after 3 months of surgery
Length of postoperative hospital stay
Record length of postoperative hospital stay
Time frame: 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
Time frame: 90 days