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

NCT ID: NCT04461964

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2023-06-30

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.

Conditions

Spinal Stenosis; Scoliosis; Spondylolisthesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

7D Surgical Inc.

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey A Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Other Identifiers

19-01201

Identifier Type: -

Identifier Source: org_study_id