Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc
NCT ID: NCT04980378
Last Updated: 2026-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
291 participants
OBSERVATIONAL
2021-08-01
2024-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Simplify Disc
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
Simplify Disc
The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.
Historical Control - Anterior Cervical Discectomy and Fusion (ACDF)
This study used a non-concurrent historical control with subject-level data on a parallel group design. The historical control group was formed from the randomized ACDF arm of a previously completed two level cervical disc trial.
No interventions assigned to this group
Interventions
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Simplify Disc
The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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* Subjects who were withdrawn or withdrew consent to participate in the IDE study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
ALL
No
Sponsors
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NuVasive
INDUSTRY
Responsible Party
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Principal Investigators
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Kyle Malone
Role: STUDY_DIRECTOR
Globus Medical
Locations
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Orthopaedic Education and Research Institute of Southern California
Orange, California, United States
The Spine Institute for Spine Restoration
Santa Monica, California, United States
Spine Education and Research Foundation
Thornton, Colorado, United States
Connecticut Orthopaedic Specialists
Hamden, Connecticut, United States
Kennedy-White Orthopedic Center
Sarasota, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
Indiana Spine Group
Carmel, Indiana, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
William Beaumont Hospital Research Institute
Royal Oak, Michigan, United States
Buffalo Spine Surgery
Lockport, New York, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States
Oregon Neurosurgery
Springfield, Oregon, United States
Texas Spine Consultants
Addison, Texas, United States
Texas Back Institute
Plano, Texas, United States
The Disc Replacement Center
West Jordan, Utah, United States
Virginia Spine Institute
Reston, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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P200022_S003_PAS
Identifier Type: -
Identifier Source: org_study_id
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