Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
1 other identifier
observational
131
1 country
10
Brief Summary
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2022
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2022
CompletedStudy Start
First participant enrolled
February 9, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
December 22, 2025
December 1, 2025
6.1 years
February 8, 2022
December 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Composite Success
Individual patient success for the primary endpoint will be assessed at 120 months and is defined as follows: 1. Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline (pre-op), and 2. No device failures by month 120, and 3. No secondary surgical intervention (SSI) at the index level (i.e., revision, removal, reoperation, or supplemental fixation) by month 120.
10 years
Secondary Outcomes (12)
Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint
10 years
Percentage of subjects meeting MCID for Visual Analog Scale (VAS) for each of the following pain locations and each annual timepoint: neck and arm pain, neck only pain, left arm pain, and right arm pain
10 years
Motor status at each annual timepoint compared to baseline
10 years
Sensory status at each annual timepoint compared to baseline
10 years
Treatment satisfaction questionnaire at each annual timepoint
10 years
- +7 more secondary outcomes
Study Arms (1)
Simplify Disc
Extended follow-up of subjects treated with the Simplify Disc during IDE G140154 and followed in the post-approval study NCT04630626.
Interventions
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
The study population includes subjects treated with the NuVasive Simplify Disc in IDE study (NCT02667067) and followed in the PAS (NCT04630626).
You may qualify if:
- Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site
- Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study
You may not qualify if:
- Subject had an SSI at the index level during the post approval study (NCT04630626)
- Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NuVasivelead
Study Sites (10)
Hoag Orthopedics
Orange, California, 92686, United States
The Spine Institute for Spine Restoration
Santa Monica, California, 90403, United States
Spine Education and Research
Thornton, Colorado, 80229, United States
Kennedy-White Orthopaedic Center
Sarasota, Florida, 34232, United States
NorthShore University Health System
Evanston, Illinois, 60201, United States
Indiana Spine Group
Carmel, Indiana, 46032, United States
Spine Institute of Louisiana
Shreveport, Louisiana, 71101, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28204, United States
Texas Spine Consultants
Addison, Texas, 75001, United States
Texas Back Institute
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2022
First Posted
February 28, 2022
Study Start
February 9, 2022
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share