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

NCT04461964 | Withdrawn DMC

• 1 other identifier: 19-01201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Stenosis; Scoliosis; Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Length of time to register images

  Visit 1 Day 1

• Length of time to place all screws

  Visit 1 Day 1

• Estimated blood loss (EBL)

  Visit 1 Day 1

• Dose of intraoperative ionizing radiation

  Visit 1 Day 1

• Screw placement accuracy

  Visit 1 Day 1

Study Arms (1)

treatment group

EXPERIMENTAL

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.

Interventions

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

treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• NYU Langone Health: lead
• 7D Surgical Inc.: collaborator

MeSH Terms

Conditions

Spinal Stenosis; Scoliosis; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Curvatures; Spondylolysis; Spondylosis

Study Officials

• Jeffrey A Goldstein, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 8, 2020
• Study Start: July 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.