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Enrolling By Invitation
NCT05691231
Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
Conditions: Cervical Disc Disease, Degenerative Disc Disease
Sex: All
Ages: 18 Years – N/A
Enrollment: 158
Sponsor: NuVasive
Location: United States
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 Criteria
Inclusion Criteria:Subject was enrolled in the Simplify Disc IDE (NCT03123549) and/or PAS (NCT04980378) at a participating study sitePatient understands the conditions of enrollment and is willing sign an informed consent form to participate in the studyExclusion Criteria:Subject had an SSI at the index level during the IDE study (NCT03123549) or the PAS (NCT04980378)Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)
Source: ClinicalTrials.gov (NCT05691231). StuddyBuddy aggregates publicly available trial information.
