Single Center, Prospective Study of the MvIGS Spine Navigation System in Posterior Fusion Utilizing Pedicle Screw Fixation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- NYU Langone Health
- Primary Endpoint
- Total length of operative time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Machine-vision Image Guided Surgery (MvIGS) spine navigation system. (Device)
Outcomes
Primary Outcomes
Total length of operative time
Time Frame: Visit 1 Day 1
The aim is to reduce operative time. Operative time will be determined by the official recorded operative notes.
Secondary Outcomes
- Length of time to register images(Visit 1 Day 1)
- Time to ambulation(Post operative hospital visit (Day 1-10))
- Time to hospital discharge after surgery(Post operative hospital visit (Day 1-10))
- Screw placement accuracy(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)
- incidence of intraoperative complications(Visit 1 Day 1)