Study to Evaluate the Safety and Clinical Outcome of Using Navigation System in Pedicle Screw Pla… (NCT04578691) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate the Safety and Clinical Outcome of Using Navigation System in Pedicle Screw Placement in Spine Surgery
Taiwan55 participantsStarted 2020-06-29
Plain-language 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.
Who can participate
Age range20 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
✕
What they're measuring
1
Rate of screw outside the vertebral body
Timeframe: not later than discharge, up to 14 days