Clinical trial · Interventional
Study to Evaluate the Safety and Clinical Outcome of Using Navigation System in Pedicle Screw Placement in Spine Surgery
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
NCT04578691CI-TRIAL-00062107completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Degenerative Spine Disease | — | UNRESOLVED | — |
| Spinal Tumor | — | UNRESOLVED | — |
| Traumatic Injury of Spine | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "Anatase" Spine Surgery Navigation System | Device | — | UNRESOLVED |
| Medtronic Stealthstation S7 Treatment Guidance System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- "Anatase" Spine Surgery Navigation System
- description
- Using "Anatase" Spine Surgery Navigation System in pedicle screw placement in spine surgery
- interventionNames
- Device: "Anatase" Spine Surgery Navigation System
- type
- ACTIVE_COMPARATOR
- label
- Medtronic Stealthstation S7 Treatment Guidance System
- description
- Using Medtronic Stealthstation S7 Treatment Guidance System in pedicle screw placement in spine surgery
- interventionNames
- Device: Medtronic Stealthstation S7 Treatment Guidance System
Primary outcomes (1)
- measure
- Rate of screw outside the vertebral body
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who need to undergo pedicle screw placement surgery with indication of spinal tumor, traumatic injury or degenerative spine disease. 2. Pedicle screws placed from 10th thoracic vertebra to first sacrum. 3. Age ≥20 years and ≤80 years. 4. Body Mass Index (BMI) \< 40 kg/m2. 5. Spine T-Score by Dual Energy X-ray Absorptiometry ≥ -2.5, 60 days prior to surgery. 6. The subject is willing and able to comply with the procedure and requirements of this trial. 7. The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements. Exclusion Criteria: 1. Pregnant women. 2. Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency. 3. Be on uncontrolled Diabetes mellitus. 4. Any history of stroke within the previous 6 months. 5. 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. 6. Any terminal illness such that the patient would not be expected to survive more than 6 months. 7. Creutzfeldt-Jakob disease. 8. Known allergy to stainless steel (device material). 9. Have a systematic or local infection, which may increase study risk. 10. Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia. 11. Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for \> 1 month within last 12 months. 12. 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. 13. Former spinal surgery may interfere with the present trial. 14. Participation in any investigational study in the last 30 days or current enrolment in any trial. Non- interventional Studies are not considered exclusion. 15. Any condition that increases anesthesia risk.
References
Publications (0)
Data not yet available
No reference posted for this study.