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

Primary Purpose

Spinal Tumor, Traumatic Injury of Spine, Degenerative Spine Disease

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

"Anatase" Spine Surgery Navigation System

Medtronic Stealthstation S7 Treatment Guidance System

About this trial

This is an interventional treatment trial for Spinal Tumor focused on measuring Pedicle screw placement surgery, 10th thoracic vertebra to 1st sacrum

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
Any terminal illness such that the patient would not be expected to survive more than 6 months.
Creutzfeldt-Jakob disease.
Known allergy to stainless steel (device material).
Have a systematic or local infection, which may increase study risk.
Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia.
Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months.
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.
Former spinal surgery may interfere with the present trial.
Participation in any investigational study in the last 30 days or current enrolment in any trial. Non- interventional Studies are not considered exclusion.
Any condition that increases anesthesia risk.

Sites / Locations

Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

"Anatase" Spine Surgery Navigation System

Medtronic Stealthstation S7 Treatment Guidance System

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Blood loss during surgery (mL)

record the blood loss during surgery (mL)

Total intraoperative radiation exposure for the operator and patient

Record the total intraoperative radiation exposure of operator and patient wearing TLD badges

Mean time required for preparation of screw placement (min)

Record the mean time required for preparation of screw placement (min)

Time to accomplish each screw insertion (min)

Record the time to accomplish each screw insertion (min)

Ratio of revision surgery within 3 months after main surgery

Record ration of revision surgery within 3 months after main surgery

Length of postoperative hospital stay

Record length of postoperative hospital stay

Adverse event (AE) and serious AE (SAE) incidence rates during the trial

Record Adverse event (AE) and serious AE (SAE) during the trial

Full Information

NCT ID

NCT04578691

First Posted

August 20, 2020

Last Updated

November 9, 2022

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT04578691

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

June 29, 2020 (Actual)

Primary Completion Date

June 3, 2022 (Actual)

Study Completion Date

August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Tumor, Traumatic Injury of Spine, Degenerative Spine Disease

Keywords

Pedicle screw placement surgery, 10th thoracic vertebra to 1st sacrum

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

"Anatase" Spine Surgery Navigation System

Arm Type

Experimental

Arm Description

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

Arm Title

Medtronic Stealthstation S7 Treatment Guidance System

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

"Anatase" Spine Surgery Navigation System

Intervention Description

using navigation system in pedicle screw placement in spine surgery

Intervention Type

Device

Intervention Name(s)

Medtronic Stealthstation S7 Treatment Guidance System

Intervention Description

using navigation system in pedicle screw placement in spine surgery

Primary Outcome Measure Information:

Title

Rate of screw outside the vertebral body

Description

Rate of screw outside the vertebral body as measure by post CT image which perform not later than discharge.

Time Frame

not later than discharge, up to 14 days

Secondary Outcome Measure Information:

Title

Difference between the actual and virtual (navigation image) of screw's sharp point position

Description

Blind Assessor will measure the distance (mm) between the actual (post-CT) and virtual (baseline CT) of screw's sharp point position.

Time Frame

not later than discharge, up to 14 days

Title

Difference between the actual and virtual (navigation image) angle of screws

Description

Blind Assessor will measure the difference of angle (°) between the actual (post-CT) and virtual (baseline CT)screws.

Time Frame

not later than discharge, up to 14 days

Title

Blood loss during surgery (mL)

Description

record the blood loss during surgery (mL)

Time Frame

operation 1 day

Title

Total intraoperative radiation exposure for the operator and patient

Description

Record the total intraoperative radiation exposure of operator and patient wearing TLD badges

Time Frame

1 day, the TLD badges will be detected

Title

Mean time required for preparation of screw placement (min)

Description

Record the mean time required for preparation of screw placement (min)

Time Frame

operation 1 day

Title

Time to accomplish each screw insertion (min)

Description

Record the time to accomplish each screw insertion (min)

Time Frame

operation 1 day

Title

Ratio of revision surgery within 3 months after main surgery

Description

Record ration of revision surgery within 3 months after main surgery

Time Frame

after 3 months of surgery

Title

Length of postoperative hospital stay

Description

Record length of postoperative hospital stay

Time Frame

Discharge day, up to 14 days

Title

Adverse event (AE) and serious AE (SAE) incidence rates during the trial

Description

Record Adverse event (AE) and serious AE (SAE) during the trial

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. Any terminal illness such that the patient would not be expected to survive more than 6 months. Creutzfeldt-Jakob disease. Known allergy to stainless steel (device material). Have a systematic or local infection, which may increase study risk. Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia. Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months. 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. Former spinal surgery may interfere with the present trial. Participation in any investigational study in the last 30 days or current enrolment in any trial. Non- interventional Studies are not considered exclusion. Any condition that increases anesthesia risk.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tsung-Hsi Tu

Organizational Affiliation

Taipei Veterans General Hospital, Taiwan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taipei Veterans General Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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