Spinal Tumor Clinical Trial
Official title:
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
Verified date | November 2022 |
Source | Taipei Veterans General Hospital, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | August 31, 2022 |
Est. primary completion date | June 3, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Veterans General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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. | not later than discharge, up to 14 days | |
Secondary | Blood loss during surgery (mL) | record the blood loss during surgery (mL) | operation 1 day | |
Secondary | 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 | |
Secondary | Mean time required for preparation of screw placement (min) | Record the mean time required for preparation of screw placement (min) | operation 1 day | |
Secondary | Time to accomplish each screw insertion (min) | Record the time to accomplish each screw insertion (min) | operation 1 day | |
Secondary | 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 | |
Secondary | Length of postoperative hospital stay | Record length of postoperative hospital stay | Discharge day, up to 14 days | |
Secondary | 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 |
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