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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04461964
• Other study ID #: 19-01201
• Status: Withdrawn
• Phase: N/A
• Start date: July 2022
• Est. completion date: June 2023

Study information

• Verified date: June 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scoliosis
• Spinal Stenosis
• Spondylolisthesis

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	7D Surgical Inc.

Outcome

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