Spinal TumorNCT04578691
Study to Evaluate the Safety and Clinical Outcome of Using Navigation System in Pedicle Screw Placement in Spine Surgery
A study testing "Anatase" Spine Surgery Navigation System and Medtronic Stealthstation S7 Treatment Guidance System in people with Spinal Tumor and Traumatic Injury of Spine, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Spinal Tumor, Traumatic Injury of Spine, Degenerative Spine Disease
- What is being tested?
- "Anatase" Spine Surgery Navigation System and Medtronic Stealthstation S7 Treatment Guidance System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jun 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- "Anatase" Spine Surgery Navigation System, Medtronic Stealthstation S7 Treatment Guidance System
- Keywords
- Pedicle screw placement surgery, 10th thoracic vertebra to 1st sacrum
- Medical subject headings
- Spinal Cord Neoplasms, Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Anatase" Spine Surgery Navigation SystemDevice
using navigation system in pedicle screw placement in spine surgery
Medtronic Stealthstation S7 Treatment Guidance SystemDevice
using navigation system in pedicle screw placement in spine surgery
| Study group | Role | What they receive |
|---|---|---|
| "Anatase" Spine Surgery Navigation System | Experimental | Using "Anatase" Spine Surgery Navigation System in pedicle screw placement in spine surgery Receives: 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 Receives: Device: Medtronic Stealthstation S7 Treatment Guidance System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Blind Assessor will measure the distance (mm) between the actual (post-CT) and virtual (baseline CT) of screw's sharp point position.
Measured: 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.
Measured: not later than discharge, up to 14 days
Blood loss during surgery (mL)
record the blood loss during surgery (mL)
Measured: 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
Measured: 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)
Measured: operation 1 day
Time to accomplish each screw insertion (min)
Record the time to accomplish each screw insertion (min)
Measured: operation 1 day
Ratio of revision surgery within 3 months after main surgery
Record ration of revision surgery within 3 months after main surgery
Measured: after 3 months of surgery
Length of postoperative hospital stay
Record length of postoperative hospital stay
Measured: 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start29 Jun 2020
- Primary completion3 Jun 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TumorStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tsung-Hsi Tu, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578691
- Sponsor's protocol ID
- 2020-03-004C
- Status last verified
- Nov 2022
- First submitted
- 20 Aug 2020
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04578691
- Acronym / sponsor ID
- 2020-03-004C
- Keywords
- Pedicle screw placement surgery, 10th thoracic vertebra to 1st sacrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Anatase" Spine Surgery Navigation System | Experimental | Device: "Anatase" Spine Surgery Navigation SystemUsing "Anatase" Spine Surgery Navigation System in pedicle screw placement in spine surgery |
| Medtronic Stealthstation S7 Treatment Guidance System | Active comparator | Device: Medtronic Stealthstation S7 Treatment Guidance SystemUsing Medtronic Stealthstation S7 Treatment Guidance System in pedicle screw placement in spine surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Anatase" Spine Surgery Navigation Systemusing navigation system in pedicle screw placement in spine surgery | Device | "Anatase" Spine Surgery Navigation System |
| Medtronic Stealthstation S7 Treatment Guidance Systemusing navigation system in pedicle screw placement in spine surgery | Device | Medtronic Stealthstation S7 Treatment Guidance System |
Primary outcome
Rate of screw outside the vertebral body
Time frame: not later than discharge, up to 14 days
Rate of screw outside the vertebral body as measure by post CT image which perform not later than discharge.
9 secondary outcomes
Difference between the actual and virtual (navigation image) of screw's sharp point position
Time frame: not later than discharge, up to 14 days
Difference between the actual and virtual (navigation image) angle of screws
Time frame: not later than discharge, up to 14 days
Blood loss during surgery (mL)
Time frame: operation 1 day
Total intraoperative radiation exposure for the operator and patient
Time frame: 1 day, the TLD badges will be detected
Mean time required for preparation of screw placement (min)
Time frame: operation 1 day
Time to accomplish each screw insertion (min)
Time frame: operation 1 day
Ratio of revision surgery within 3 months after main surgery
Time frame: after 3 months of surgery
Length of postoperative hospital stay
Time frame: Discharge day, up to 14 days
Adverse event (AE) and serious AE (SAE) incidence rates during the trial
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsung-Hsi Tu principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Anatase" Spine Surgery Navigation System and Medtronic Stealthstation S7 Treatment Guidance System in people with Spinal Tumor and Traumatic Injury of Spine, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of screw outside the vertebral body (time frame: not later than discharge, up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.