This is a multi-center, non-randomized post marketing surveillance registry including up to 125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should be per standard of care.
For all patients participating in the registry, the following outcomes will be analyzed: * Change in pain score on the Visual Analog Scale(VAS) from baseline for leg pain * Change in pain score on the Visual Analog Scale(VAS) from baseline for back pain * Change in Oswestry Disability Index (ODI) score from baseline * Proportion of patients with a device related complication * Proportion of patients with lack of revision, removal, or reoperation * Proportion of patients with radiographic fusion
Study Type
OBSERVATIONAL
Enrollment
125
Los Angeles Brain and Spine Institute
Los Angeles, California, United States
RECRUITINGFlagler Hospital
Saint Augustine, Florida, United States
RECRUITINGFusion
Image Assessment
Time frame: 1 year
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