Back to resultsEffects of a Spine Navigation System on Op-time and Radiation Exposure
Primary Purpose
Spinal Stenosis, Scoliosis, Spondylolisthesis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Machine-vision Image Guided Surgery (MvIGS) spine navigation system.
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Stenosis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of spinal stenosis of the lumbar spine with degenerative spondylolisthesis, all grades, and planning to undergo surgical fusion;
- Skeletally mature adults between the ages of 18-85 years at the time of surgery;
- Has completed at least 6 months of conservative therapy for degenerative diagnosis, if appropriate; and,
- Personally signed and dated an informed consent document prior to any study-related procedures, indicating that the patient has been informed of all pertinent aspects of the study.
Exclusion Criteria:
- History of malignancy, craniocervical junction pathology, cervical and thoracic locations, and/or previous lumbar operation;
- Significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other than spinal stenosis;
- Significant peripheral vascular disease (defined as diminished dorsalis pedis or tibial pulses);
- Morbid obesity, defined as BMI > 40 kg/m2;
- Active systemic or local infection;
- Active hepatitis (defined as receiving medical treatment within two years);
- Immunocompromised, such as but not limited to being diagnosed with Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, or Thymic Hypoplasia;
- Insulin-dependent diabetes mellitus or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing;
- Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months;
- History of Paget's disease, osteomalacia, or any other metabolic bone disease;
- Involved in study of another investigational product that may affect outcome;
- Women who are pregnant, lactating or anticipate becoming pregnant within 24 months post-surgery;
- Non-English speaking;
- Patients who are incarcerated;
- Worker's compensation cases; or,
- Patients involved in active litigation relating to his/her spinal condition.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
Eligible participants will be identified by their treating physician and referred to the study research coordinator for enrollment. NYU standard practice in relation to pre-operative and intra-operative imaging studies will be explained. The role of the MvIGS system in this study will then also be explained. In each subject, they will perform posterior instrumentation utilizing the MvIGS spine navigation system for pedicle screw guidance and record data for intraoperative study endpoints
Outcomes
Primary Outcome Measures
Total length of operative time
The aim is to reduce operative time. Operative time will be determined by the official recorded operative notes.
Secondary Outcome Measures
Length of time to register images
Aim: To reduce time for registration of reference images Measured: Seconds
Length of time to place all screws
Aim: To reduce the time for screw placement Measured: Minutes
Estimated blood loss (EBL)
Aim: To reduce the EBL of each case Measured: Millilitres (mL)
Dose of intraoperative ionizing radiation
Aim: To reduce intraoperative ionizing radiation Measured: Total amount of the radiation dose in millisievert (mSv)
Screw placement accuracy
Aim: To improve screw placement accuracy Measured: Graded using radiographic classification and clinical revision rate
incidence of intraoperative complications
Aim: To decrease the incidence of intraoperative complications Measured: Number of reported complications
Time to ambulation
Aim: To reduce time to ambulation Measured: Days
Time to hospital discharge after surgery
Aim: To reduce hospital length of stay Measured: Days
Full Information
NCT ID
NCT04461964
First Posted
June 30, 2020
Last Updated
June 8, 2022
Sponsor
NYU Langone Health
Collaborators
7D Surgical Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04461964
Brief Title
Effects of a Spine Navigation System on Op-time and Radiation Exposure
Official Title
Single Center, Prospective Study of the MvIGS Spine Navigation System in Posterior Fusion Utilizing Pedicle Screw Fixation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
funding for the study has stopped
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
7D Surgical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to prospectively collect information about the operative time and intraoperative radiation experienced by patients undergoing posterior spinal fusion procedures guided by the MvIGS spine navigation system.
Detailed Description
This is a single-center, prospective case series to assess the use of the Machine-vision Image Guided Surgery (MvIGS) spine navigation system for treatment of spinal stenosis, scoliosis, and spondylolisthesis that requires fusion. This is a single-arm, open-label study. All participants will undergo their single and multi-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under MvIGS intraoperative navigation guidance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis, Scoliosis, Spondylolisthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
Eligible participants will be identified by their treating physician and referred to the study research coordinator for enrollment. NYU standard practice in relation to pre-operative and intra-operative imaging studies will be explained. The role of the MvIGS system in this study will then also be explained. In each subject, they will perform posterior instrumentation utilizing the MvIGS spine navigation system for pedicle screw guidance and record data for intraoperative study endpoints
Intervention Type
Device
Intervention Name(s)
Machine-vision Image Guided Surgery (MvIGS) spine navigation system.
Intervention Description
The intended use of the MvIGS navigation system is to provide high quality intraoperative imaging with no radiation exposure. Use of the proprietary integrated surgical light with embedded tracking technology and Flash™ registration allows for continuous and direct visualization of the surgical field. The MvIGS system is exempt from IDE regulations as the device cleared Premarket Notification FDA-510(k) (K162375). The device includes:
A single mobile cart with a boom arm and an integrated surgical light with embedded tracking technology (P/N 10-0001);
Proprietary imaging software (P/N 60-0007); and,
Kit of tacked surgical instruments including a spine reference clamp, awl tip, pedicle probe (P/N 11-0006).
Primary Outcome Measure Information:
Title
Total length of operative time
Description
The aim is to reduce operative time. Operative time will be determined by the official recorded operative notes.
Time Frame
Visit 1 Day 1
Secondary Outcome Measure Information:
Title
Length of time to register images
Description
Aim: To reduce time for registration of reference images Measured: Seconds
Time Frame
Visit 1 Day 1
Title
Length of time to place all screws
Description
Aim: To reduce the time for screw placement Measured: Minutes
Time Frame
Visit 1 Day 1
Title
Estimated blood loss (EBL)
Description
Aim: To reduce the EBL of each case Measured: Millilitres (mL)
Time Frame
Visit 1 Day 1
Title
Dose of intraoperative ionizing radiation
Description
Aim: To reduce intraoperative ionizing radiation Measured: Total amount of the radiation dose in millisievert (mSv)
Time Frame
Visit 1 Day 1
Title
Screw placement accuracy
Description
Aim: To improve screw placement accuracy Measured: Graded using radiographic classification and clinical revision rate
Time Frame
Visit 1 Day 1
Title
incidence of intraoperative complications
Description
Aim: To decrease the incidence of intraoperative complications Measured: Number of reported complications
Time Frame
Visit 1 Day 1
Title
Time to ambulation
Description
Aim: To reduce time to ambulation Measured: Days
Time Frame
Post operative hospital visit (Day 1-10)
Title
Time to hospital discharge after surgery
Description
Aim: To reduce hospital length of stay Measured: Days
Time Frame
Post operative hospital visit (Day 1-10)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of spinal stenosis of the lumbar spine with degenerative spondylolisthesis, all grades, and planning to undergo surgical fusion;
Skeletally mature adults between the ages of 18-85 years at the time of surgery;
Has completed at least 6 months of conservative therapy for degenerative diagnosis, if appropriate; and,
Personally signed and dated an informed consent document prior to any study-related procedures, indicating that the patient has been informed of all pertinent aspects of the study.
Exclusion Criteria:
History of malignancy, craniocervical junction pathology, cervical and thoracic locations, and/or previous lumbar operation;
Significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other than spinal stenosis;
Significant peripheral vascular disease (defined as diminished dorsalis pedis or tibial pulses);
Morbid obesity, defined as BMI > 40 kg/m2;
Active systemic or local infection;
Active hepatitis (defined as receiving medical treatment within two years);
Immunocompromised, such as but not limited to being diagnosed with Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, or Thymic Hypoplasia;
Insulin-dependent diabetes mellitus or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing;
Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months;
History of Paget's disease, osteomalacia, or any other metabolic bone disease;
Involved in study of another investigational product that may affect outcome;
Women who are pregnant, lactating or anticipate becoming pregnant within 24 months post-surgery;
Non-English speaking;
Patients who are incarcerated;
Worker's compensation cases; or,
Patients involved in active litigation relating to his/her spinal condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Goldstein, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Jeffrey.goldstein@nyulangone.org . To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Effects of a Spine Navigation System on Op-time and Radiation Exposure
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