CompletedNot Applicable

Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc

United States291 participantsStarted 2021-08-01

Plain-language summary

This study is intended to demonstrate the 5-year long-term safety and efficacy of the Simplify® Cervical Artificial Disc ("Simplify Disc") in subjects enrolled in the non-randomized two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206

Who can participate

SexALL

See this in plain English?

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Inclusion Criteria: \- All subjects enrolled in the two level Simplify Disc IDE study are considered for this long-term follow-up study. Exclusion Criteria: * Subjects who were not implanted with the Simplify Disc during the IDE study * Subjects who had a secondary surgical intervention at the index level during the IDE study * Subjects who were withdrawn or withdrew consent to participate in the IDE study * Subjects who do not consent to participate in long-term follow-up post-approval study

What they're measuring

Clinical Composite Success

Timeframe: Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported

Trial details

NCT IDNCT04980378

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-01-24

Results submitted2025-01-30

View on ClinicalTrials.gov More Cervical Degenerative Disc Disorder trials