By InvitationNot Applicable

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

United States158 participantsStarted 2023-01-18

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

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 Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)

What they're measuring

Clinical Composite Success Rate

Timeframe: 10 years

Trial details

NCT IDNCT05691231

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-02-10

View on ClinicalTrials.gov More Cervical Disc Disease trials