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

Not Applicable

Withdrawn

• Conditions: Spinal Stenosis; Scoliosis; Spondylolisthesis
• Interventions: Device: Machine-vision Image Guided Surgery (MvIGS) spine navigation system.

• Registration Number: NCT04461964
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-08
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-13
• Study Start: 2022-07
• Primary Completion: 2023-02
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	Machine-vision Image Guided Surgery (MvIGS) spine navigation system.	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

Primary Outcome Measures

Name	Time	Method
Total length of operative time	Visit 1 Day 1	The aim is to reduce operative time. Operative time will be determined by the official recorded operative notes.

Secondary Outcome Measures

Name	Time	Method
Time to hospital discharge after surgery	Post operative hospital visit (Day 1-10)	Aim: To reduce hospital length of stay Measured: Days
Length of time to register images	Visit 1 Day 1	Aim: To reduce time for registration of reference images Measured: Seconds
Time to ambulation	Post operative hospital visit (Day 1-10)	Aim: To reduce time to ambulation Measured: Days
Screw placement accuracy	Visit 1 Day 1	Aim: To improve screw placement accuracy Measured: Graded using radiographic classification and clinical revision rate
Length of time to place all screws	Visit 1 Day 1	Aim: To reduce the time for screw placement Measured: Minutes
Estimated blood loss (EBL)	Visit 1 Day 1	Aim: To reduce the EBL of each case Measured: Millilitres (mL)
Dose of intraoperative ionizing radiation	Visit 1 Day 1	Aim: To reduce intraoperative ionizing radiation Measured: Total amount of the radiation dose in millisievert (mSv)
incidence of intraoperative complications	Visit 1 Day 1	Aim: To decrease the incidence of intraoperative complications Measured: Number of reported complications