Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc
Public ClinicalTrials.gov record NCT04980378. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04980378
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 291 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 1, 2021 (Actual)
- Primary completion
- Jan 24, 2024 (Actual)
- Completion
- Jan 24, 2024 (Actual)
- Last update posted
- Jan 8, 2026
2021 – 2024
United States locations
- U.S. sites
- 18
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Orthopaedic Education and Research Institute of Southern California | Orange | California | 92868 | — |
| The Spine Institute for Spine Restoration | Santa Monica | California | 90403 | — |
| Spine Education and Research Foundation | Thornton | Colorado | 80229 | — |
| Connecticut Orthopaedic Specialists | Hamden | Connecticut | 06518 | — |
| Kennedy-White Orthopedic Center | Sarasota | Florida | 34232 | — |
| NorthShore University Health System | Evanston | Illinois | 60201 | — |
| Indiana Spine Group | Carmel | Indiana | 46032 | — |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | — |
| Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | 42003 | — |
| Spine Institute of Louisiana | Shreveport | Louisiana | 71101 | — |
| William Beaumont Hospital Research Institute | Royal Oak | Michigan | 48073 | — |
| Buffalo Spine Surgery | Lockport | New York | 14094 | — |
| Carolina Neurosurgery and Spine Associates | Charlotte | North Carolina | 28204 | — |
| Oregon Neurosurgery | Springfield | Oregon | 97477 | — |
| Texas Spine Consultants | Addison | Texas | 75001 | — |
| Texas Back Institute | Plano | Texas | 75093 | — |
| The Disc Replacement Center | West Jordan | Utah | 84088 | — |
| Virginia Spine Institute | Reston | Virginia | 20191 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04980378, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 8, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04980378 live on ClinicalTrials.gov.