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Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

Overview Structured Data Issues Contributors

clinicaltrials.gov/study/NCT04630626

Is a

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Clinical Study attributes

NCT Number

Trial Recruitment Size

1420

Trial Sponsor

0

Clinical Trial Start Date

January 1, 2021

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Primary Completion Date

March 23, 2023

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Study Completion Date

June 23, 2023

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Clinical Trial Study Type

Observational0

Intervention Type

Device0

Intervention Name

Simplify Disc0

Observational Clinical Trial Type

Case-Only0

Observational Study Perspective

Prospective0

Participating Facility

Virginia Spine Institute

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Rothman Institute

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Indiana Spine Group

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Texas Back Institute

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Official Name

Extended Follow-up of Investigational Device Exemption (IDE) Subjects Treated With the Simplify Cervical Artificial Disc0

Last Updated

October 7, 2022

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Study 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.

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Further Resources

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