Spondylolisthesis Clinical Trial
Official title:
A Single-Center, Prospective Cohort Study of the Machine-vision Image Guided Surgery (MvIGS) Spine Navigation System
NCT number | NCT03968965 |
Other study ID # | 2018-0328 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 9, 2018 |
Est. completion date | November 1, 2019 |
Verified date | March 2021 |
Source | 7D Surgical Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study assesses clinical outcomes following the use of the MvIGS spine navigation system for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar spine in adults. There will be separate study arms for cases utilizing the three-dimensional (3D) MvIGS spine navigation system and cases that utilize conventional two-dimensional (2D) fluoroscopy.
Status | Completed |
Enrollment | 64 |
Est. completion date | November 1, 2019 |
Est. primary completion date | November 1, 2019 |
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 = grade 2 degenerative spondylolisthesis - Skeletally mature adults between the ages of 18-85 years at the time of surgery - Has completed at least 6 months of conservative therapy - Personally signed and dated 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: - Gross instability, defined as > 3 mm translational motion on flexion/extension studies - Degenerative spondylolisthesis > grade 2 - Degenerative scoliosis > 10° at any level in lumbar spine - Congenital lumbar spinal stenosis - Endplate changes - Visible change in disc height - Radiographic confirmation of facet joint disease or degeneration - Prior surgery at any lumbar level including the level being treated except for: Lamino/Foraminotomy, Microdiscectomy, IDET, and Percutaneous Discectomy - Any evidence of a prior/current fracture, compromised vertebra, current or past trauma, or tumor at affected level or the spinous processes at the adjacent levels - Requires destabilizing surgical decompression that adversely affects the functioning of the facets - Cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence) - Significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other than spinal stenosis - Significant peripheral vascular disease (diminished dorsalis pedis or tibial pulses) - Morbid obesity, defined as BMI > 40 kg/m2 - Active systemic or local infection - Active Hepatitis (receiving medical treatment within two years) - Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, 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 - Active malignancy. A patient with a history of any invasive malignancy (except nonmelanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy >5 years - 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 - Patients who are incarcerated - Worker's compensation cases - Patients involved in active litigation relating to his/her spinal condition |
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
7D Surgical Inc. | Hospital for Special Surgery, New York |
United States,
Guha D, Jakubovic R, Alotaibi NM, Klostranec JM, Saini S, Deorajh R, Gupta S, Fehlings MG, Mainprize TG, Yee A, Yang VXD. Optical Topographic Imaging for Spinal Intraoperative Three-Dimensional Navigation in Mini-Open Approaches: A Prospective Cohort Study of Initial Preclinical and Clinical Feasibility. World Neurosurg. 2019 May;125:e863-e872. doi: 10.1016/j.wneu.2019.01.201. Epub 2019 Feb 8. — View Citation
Jakubovic R, Guha D, Gupta S, Lu M, Jivraj J, Standish BA, Leung MK, Mariampillai A, Lee K, Siegler P, Skowron P, Farooq H, Nguyen N, Alarcon J, Deorajh R, Ramjist J, Ford M, Howard P, Phan N, Costa LD, Heyn C, Tan G, George R, Cadotte DW, Mainprize T, Yee A, Yang VXD. High Speed, High Density Intraoperative 3D Optical Topographical Imaging with Efficient Registration to MRI and CT for Craniospinal Surgical Navigation. Sci Rep. 2018 Oct 5;8(1):14894. doi: 10.1038/s41598-018-32424-z. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Total Length of Operative Time | Operative time determined by the official recorded operative notes | Data captured up to four hours after end of surgery | |
Secondary | Length of Stay | Length of hospital stay | Data captured upon patient discharge. | |
Secondary | Estimated Blood Loss (EBL) | Blood loss during surgery | During surgery | |
Secondary | Number of Misaligned Screws | Number of screws that were misaligned as defined by discrepancies between the pilot hole and preoperative plan and final screw trajectory. | During hospital admission after surgery, an average of approximately 14 days | |
Secondary | Complications | Number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized | During hospital admission after surgery, an average of approximately 14 days | |
Secondary | Measurement of Radiation Exposure | Exposure measured by Dose Area Product (DAP) | During surgery | |
Secondary | Radiation Exposure Time | Radiation exposure time | During surgery |
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