Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels

Enrolling by invitation

Conditions studied: Cervical Disc Disease, Degenerative Disc Disease

In brief

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).

Key facts

Study ID

NCT05691231

Run by

NuVasive

People needed

158

Starts

2023-01-18

Expected to finish

2029-05-10

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject was enrolled in the Simplify Disc IDE (NCT03123549) and/or PAS (NCT04980378) at a participating study site
• Patient understands the conditions of enrollment and is willing sign an informed consent form to participate in the study

You may not qualify if…

• 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• Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)

Where it is running

• Carolina Neurosurgery and Spine Associates — Charlotte, North Carolina, United States
• Texas Back Institute — Plano, Texas, United States

Full record on ClinicalTrials.gov

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