Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04578691
Study type Interventional
Source Taipei Veterans General Hospital, Taiwan
Contact
Status Completed
Phase N/A
Start date June 29, 2020
Completion date August 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT03668522 - Clinical Research of H3F3AK27M in Spinal Glioma and Its Impact on TMZ Chemoradiotherapy
Active, not recruiting NCT03956537 - PMCF Neo Pedicle Screw and Cage Systems
Completed NCT03585699 - Percutaneous Fluoroscopic vs CT Guided Core Needle Biopsy for Spinal Infection and Tumor N/A
Withdrawn NCT03893110 - Carbon PEEK Versus Titanium Pedicle Screws in the Treatment of Spinal Tumors N/A
Not yet recruiting NCT06161974 - Study of Olutasidenib and Temozolomide in HGG Phase 2
Completed NCT01624220 - A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy N/A
Not yet recruiting NCT05369689 - Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics
Recruiting NCT05296889 - Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Completed NCT02252185 - A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery N/A
Recruiting NCT06120426 - En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.
Recruiting NCT05170815 - Clariance ErYs Registry
Active, not recruiting NCT03052738 - Medical Marijuana in the Pediatric Central Nervous System Tumor Population
Completed NCT04952818 - The Value of Preoperative Diagnosis and Prognostic Prediction Based on Radiomics of Giant Cell Tumor of Spine
Recruiting NCT03398915 - The European Robotic Spinal Instrumentation (EUROSPIN) Study
Recruiting NCT04217525 - Duke Spine Outcome Study (DSOS)
Enrolling by invitation NCT05106179 - The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma Phase 4
Completed NCT02613390 - Safety Evaluation of Intra-Operative MRI-Based Guidance for Laser Ablation of Epidural Metastasis N/A
Completed NCT02790294 - Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal N/A
Not yet recruiting NCT05396222 - A Prospective Study of the Safety and Efficacy of 3D-printed Non-rigid Biomimetic Implant in Cervical and Thoracolumbar Spine N/A
Recruiting NCT05631002 - Chemical Shift Encoding-based Water-fat Magnetic Resonance Imaging in Spinal Tumors