Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
NuVasive
Summary
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc at two levels in subjects who were enrolled in the IDE study (NCT03123549) and/or post approval study (NCT04980378).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject was enrolled in the Simplify Disc IDE (NCT03123549) and/or PAS (NCT04980378) at a participating study site 2. Patient understands the conditions of enrollment and is willing sign an informed consent form to participate in the study Exclusion Criteria: 1. Subject had an SSI at the index level during the IDE study (NCT03123549) or the PAS (NCT04980378) 2. Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)
Interventions
- DeviceNuVasive Simplify Cervical Artificial Disc
Simplify Disc is a weight-bearing cervical artificial disc implant consisting of PEEK (polyetheretherketone) endplates and one semi-constrained, fully articulating, mobile Zirconia Toughened Alumina ceramic (ZTA) core.
Locations (2)
- Carolina Neurosurgery and Spine AssociatesCharlotte, North Carolina
- Texas Back InstitutePlano, Texas