CompletedNot Applicable

Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

United States145 participantsStarted 2021-01-01

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 Simplify Disc IDE study. This study was conducted under IDE G140154.

Who can participate

SexALL

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Inclusion Criteria: \- All subjects enrolled in the 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study * Subjects who had a secondary surgical intervention at the index level during the IDE study * Subjects who were withdrawn or withdrew consent to participate in the IDE study * Subjects who do not consent to participate in long-term follow-up post-approval study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

Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS)

Timeframe: IDE study 24 months + PAS 36 months = 60 months total

Trial details

NCT IDNCT04630626

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-23

Results submitted2023-11-07

View on ClinicalTrials.gov More Cervical Degenerative Disc Disorder trials