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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Tumor; Traumatic Injury of Spine; Degenerative Spine Disease
• Intervention / Treatment: Device: "Anatase" Spine Surgery Navigation System; Device: Medtronic Stealthstation S7 Treatment Guidance System

Detailed 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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Anatase" Spine Surgery Navigation System; Using "Anatase" Spine Surgery Navigation System in pedicle screw placement in spine surgery	Device: "Anatase" Spine Surgery Navigation System; using navigation system in pedicle screw placement in spine surgery
Active Comparator: Medtronic Stealthstation S7 Treatment Guidance System; Using Medtronic Stealthstation S7 Treatment Guidance System in pedicle screw placement in spine surgery	Device: Medtronic Stealthstation S7 Treatment Guidance System; using navigation system in pedicle screw placement in spine surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Blood loss during surgery (mL)	record the blood loss during surgery (mL)	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	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)	operation 1 day
Time to accomplish each screw insertion (min)	Record the time to accomplish each screw insertion (min)	operation 1 day
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
Length of postoperative hospital stay	Record length of postoperative hospital stay	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	90 days

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Tsung-Hsi Tu, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): June 3, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pedicle screw placement surgery; 10th thoracic vertebra to 1st sacrum
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Bone Diseases; Back Injuries; Bone Neoplasms; Wounds and Injuries; Spinal Diseases; Spinal Injuries; Spinal Cord Neoplasms; Spinal Neoplasms; Physiological Effects of Drugs; Protective Agents; Photosensitizing Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents; Titanium dioxide
• Other Study ID Numbers: 2020-03-004C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No