Active — Not RecruitingNot Applicable

Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc

United States131 participantsStarted 2022-02-09

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 in subjects who were enrolled in the post approval study (NCT04630626).

Who can participate

SexALL

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Inclusion criteria

✓. Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site
✓. Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study

Exclusion criteria

✕. Subject had an SSI at the index level during the post approval study (NCT04630626)
✕. Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)

What they're measuring

Clinical Composite Success

Timeframe: 10 years

Trial details

NCT IDNCT05258435

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-04

View on ClinicalTrials.gov More Cervical Disc Disease trials