Study to Evaluate the Safety and Clinical Outcome of Using Navigation System in Pedicle Screw Placement in Spine Surgery

NCT ID: NCT04578691

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2022-08-31

Brief 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.

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.

Conditions

Spinal Tumor; Traumatic Injury of Spine; Degenerative Spine Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

"Anatase" Spine Surgery Navigation System

Using "Anatase" Spine Surgery Navigation System in pedicle screw placement in spine surgery

Group Type: EXPERIMENTAL

"Anatase" Spine Surgery Navigation System

Intervention Type: DEVICE

using navigation system in pedicle screw placement in spine surgery

Medtronic Stealthstation S7 Treatment Guidance System

Using Medtronic Stealthstation S7 Treatment Guidance System in pedicle screw placement in spine surgery

Group Type: ACTIVE_COMPARATOR

Medtronic Stealthstation S7 Treatment Guidance System

Intervention Type: DEVICE

using navigation system in pedicle screw placement in spine surgery

Interventions

"Anatase" Spine Surgery Navigation System

using navigation system in pedicle screw placement in spine surgery

Intervention Type: DEVICE

Medtronic Stealthstation S7 Treatment Guidance System

using navigation system in pedicle screw placement in spine surgery

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsung-Hsi Tu

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2020-03-004C

Identifier Type: -

Identifier Source: org_study_id