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

NCT04578691 | Completed

• 1 other identifier: 2020-03-004C
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Tumor; Traumatic Injury of Spine; Degenerative Spine Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Difference between the actual and virtual (navigation image) 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

  not later than discharge, up to 14 days

• Blood loss during surgery (mL)

  operation 1 day

• Total intraoperative radiation exposure for the operator and patient

  1 day, the TLD badges will be detected

• Mean time required for preparation of screw placement (min)

  operation 1 day

Study Arms (2)

"Anatase" Spine Surgery Navigation System

EXPERIMENTAL

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

Device: "Anatase" Spine Surgery Navigation System

Medtronic Stealthstation S7 Treatment Guidance System

ACTIVE COMPARATOR

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

Device: Medtronic Stealthstation S7 Treatment Guidance System

Interventions

"Anatase" Spine Surgery Navigation System DEVICE

using navigation system in pedicle screw placement in spine surgery

"Anatase" Spine Surgery Navigation System

Medtronic Stealthstation S7 Treatment Guidance System DEVICE

using navigation system in pedicle screw placement in spine surgery

Medtronic Stealthstation S7 Treatment Guidance System

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Any condition that increases anesthesia risk.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Spinal Cord Neoplasms; Spinal Injuries

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Back Injuries; Wounds and Injuries

Study Officials

• Tsung-Hsi Tu

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: October 8, 2020
• Study Start: June 29, 2020
• Primary Completion: June 3, 2022
• Study Completion: August 31, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)