This study is being undertaken to compare the clinical outcomes of patients that have unilateral posterolateral lumbar interbody fusion using a traditional open approach versus the MiLIF procedure based on the MiCOR Precision Bone Allograft, specialized Atavi instrumentation, and minimally invasive visualization capabilities.
This is a prospective, multi-center, non-randomized cohort design clinical study to evaluate the clinical outcomes of patients that have a minimally invasive lumbar interbody fusion (MiLIF) through the Atavi system compared to traditional unilateral open lumbar interbody fusion through a midline incision. the study will involve up to approximately 12 investigational sites and enroll up to 126 patients.
Study Type
OBSERVATIONAL
Enrollment
113
The primary device in the Atavi system is the Flex Posture retractor and accessories such as dilators and an Expander Instrument. The Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. Once the retractor is in place, the visualization components of the system may be used.
La Jolla Spine Institute
La Jolla, California, United States
Sharp Rees-Stealy Medical Group
San Diego, California, United States
Advanced Orthopedic Center
Port Charlotte, Florida, United States
Southeastern Spine Center
Clinical Outcomes
Time frame: MiLIF and Open groups at 3 months post-procedure as defined by the mean Oswestry score
Clinical Outcomes
Time frame: The percent of patients that have a successful fusion at one year post-procedure as measured by radiographs
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