Effects of a Spine Navigation System on Op-time and Radiation Exposure (NCT04461964) | Clinical Trial Compass
WithdrawnNot Applicable
Effects of a Spine Navigation System on Op-time and Radiation Exposure
Stopped: funding for the study has stopped
0Started 2022-07
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 steroid…