Clinical trial NCT04461964: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Stenosis
Scoliosis
Spondylolisthesis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: 7D Surgical Inc.
First posted: 2020-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Total length of operative time
timeFrame: Visit 1 Day 1
Secondary outcomes:
measure: Length of time to register images
timeFrame: Visit 1 Day 1
measure: Length of time to place all screws
timeFrame: Visit 1 Day 1
measure: Estimated blood loss (EBL)
timeFrame: Visit 1 Day 1
measure: Dose of intraoperative ionizing radiation
timeFrame: Visit 1 Day 1
measure: Screw placement accuracy
timeFrame: Visit 1 Day 1
measure: incidence of intraoperative complications
timeFrame: Visit 1 Day 1
measure: Time to ambulation
timeFrame: Post operative hospital visit (Day 1-10)
measure: Time to hospital discharge after surgery
timeFrame: Post operative hospital visit (Day 1-10)
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Jeffrey A Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References: