SurGenTec LLC
The purpose of this observational, multi-center, ambispective, serial case study is to collect real-world patient outcomes that characterize the long-term safety and effectiveness of the SurGenTec ION 3D® Facet Screw System in a cervical spine and a lumbar spine application.
The statistical analysis of the data obtained from this study will be performed using a validated statistical software program such as SPSS®. All tests will be performed at the 0.05 significance level, unless otherwise specified. Analysis will be based upon the treated population defined as all subjects that underwent standard of care surgical intervention with the SurGenTec ION 3D Facet Screw System that agreed to participate in this data collection initiative. Data collected in this study will be documented using summary tables and subject data listings. Continuous variables will be summari…
Inclusion Criteria: * Previously implanted intra-facet with one ION® Facet Screw placed per joint bilaterally at one or more contiguous levels of the cervical spine (C3-C7), or one or more contiguous levels of the lumbar spine (L3-S1), * Must have supplemental fixation at the target level(s), * Skeletally mature (minimum age of 21 years but not greater than 80 years), * Be willing and able to comply with the study protocol requirements, and * Be willing to sign the study-specific Informed Consent Document. Exclusion Criteria: * Implanted with the ION Facet Screw System at a spinal level tha…
Observational study of subjects previously implanted with ION 3D Facet Screw System.
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