Effects of a Spine Navigation System on Op-time and Radiation Exposure

Single Center, Prospective Study of the MvIGS Spine Navigation System in Posterior Fusion Utilizing Pedicle Screw Fixation

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.

Study Overview

• Status: Withdrawn
• Conditions: Scoliosis; Spinal Stenosis; Spondylolisthesis
• Intervention / Treatment: Device: Machine-vision Image Guided Surgery (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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: treatment group; 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

Device: Machine-vision Image Guided Surgery (MvIGS) spine navigation system.; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total length of operative time	The aim is to reduce operative time. Operative time will be determined by the official recorded operative notes.	Visit 1 Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of time to register images	Aim: To reduce time for registration of reference images Measured: Seconds	Visit 1 Day 1
Length of time to place all screws	Aim: To reduce the time for screw placement Measured: Minutes	Visit 1 Day 1
Estimated blood loss (EBL)	Aim: To reduce the EBL of each case Measured: Millilitres (mL)	Visit 1 Day 1
Dose of intraoperative ionizing radiation	Aim: To reduce intraoperative ionizing radiation Measured: Total amount of the radiation dose in millisievert (mSv)	Visit 1 Day 1
Screw placement accuracy	Aim: To improve screw placement accuracy Measured: Graded using radiographic classification and clinical revision rate	Visit 1 Day 1
incidence of intraoperative complications	Aim: To decrease the incidence of intraoperative complications Measured: Number of reported complications	Visit 1 Day 1
Time to ambulation	Aim: To reduce time to ambulation Measured: Days	Post operative hospital visit (Day 1-10)
Time to hospital discharge after surgery	Aim: To reduce hospital length of stay Measured: Days	Post operative hospital visit (Day 1-10)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: 7D Surgical Inc.
• Investigators: Principal Investigator: Jeffrey A Goldstein, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): February 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (ACTUAL): July 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Spondylolysis; Spondylosis; Scoliosis; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: 19-01201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No