Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
NCT ID: NCT05258435
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
131 participants
OBSERVATIONAL
2022-02-09
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Simplify Disc
Extended follow-up of subjects treated with the Simplify Disc during IDE G140154 and followed in the post-approval study NCT04630626.
NuVasive Simplify Cervical Artificial Disc
Simplify Disc is a weight-bearing cervical artificial disc implant consisting of PEEK (polyetheretherketone) endplates and one semi-constrained, fully articulating, mobile Zirconia Toughened Alumina ceramic (ZTA) core.
Interventions
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NuVasive Simplify Cervical Artificial Disc
Simplify Disc is a weight-bearing cervical artificial disc implant consisting of PEEK (polyetheretherketone) endplates and one semi-constrained, fully articulating, mobile Zirconia Toughened Alumina ceramic (ZTA) core.
Eligibility Criteria
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Inclusion Criteria
2. Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study
Exclusion Criteria
2. Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)
ALL
No
Sponsors
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NuVasive
INDUSTRY
Responsible Party
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Locations
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Hoag Orthopedics
Orange, California, United States
The Spine Institute for Spine Restoration
Santa Monica, California, United States
Spine Education and Research
Thornton, Colorado, United States
Kennedy-White Orthopaedic Center
Sarasota, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
Indiana Spine Group
Carmel, Indiana, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States
Texas Spine Consultants
Addison, Texas, United States
Texas Back Institute
Plano, Texas, United States
Countries
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Other Identifiers
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NUVA.TDR0921
Identifier Type: -
Identifier Source: org_study_id