Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Degenerative Disc Disorder
• Intervention / Treatment: Device: Simplify Disc; Other: ACDF

Detailed Description

This post approval study (PAS) is a continuation of the IDE pivotal study (G140154) as required under P200022. These data include long-term follow-up of subjects enrolled and treated under the IDE study from February 2016 to 2018 out to 60 months post-op. The control group is comprised of a historical ACDF population. Subjects were enrolled (signed consent) into the PAS on a rolling basis at either the 36 month, 48 month or 60 month visit based on their treatment date (under IDE G140154) and the date of PAS protocol approval. Data presented are compared to baseline data collected as part of the IDE study. Therefore, the start date and end dates of the PAS are not inclusive of the full 60 months of reported data.

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Orthopaedic Education and Research Institute of Southern California
    • San Diego, California, United States, 92121
      • USCD
    • Santa Monica, California, United States, 90403
      • The Spine Institute for Spine Restoration
  • Colorado
    • Thornton, Colorado, United States, 80229
      • Spine Education and Research Foundation
  • Florida
    • Sarasota, Florida, United States, 34232
      • Kennedy-White orthopedic Center
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University Health System
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Indiana Spine Group
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Orthopaedic Institute of Western Kentucky
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Spine Institute of Louisiana
  • New Jersey
    • Egg Harbor, New Jersey, United States, 08234
      • Rothman Institute
  • New York
    • Lockport, New York, United States, 14094
      • Buffalo Spine Surgery
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolina Neurosurgery and Spine Associates
  • Texas
    • Addison, Texas, United States, 75001
      • Texas Spine Consultants
    • Plano, Texas, United States, 75093
      • Texas Back Institute
  • Virginia
    • Reston, Virginia, United States, 20191
      • Virginia Spine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

The population will include subjects that were previously enrolled in the Simplify Disc IDE study and meet the inclusion/exclusion criteria for this study.

Description

Inclusion Criteria:

- All subjects enrolled in the Simplify Disc IDE study are considered for this long-term follow-up study.

Exclusion Criteria:

• Subjects who were not implanted with the Simplify Disc during the IDE study
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simplify Disc; Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154	Device: 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.
Other: Historical ACDF Control; Historical ACDF Data from similar protocol used as control.	Other: ACDF; Historical ACDF control data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS)	Individual success for Simplify Disc and the historical control Anterior Cervical Discectomy and Fusion (ACDF) is defined as follows: Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline in the Simplify Disc IDE study, and; No device failures by Month 60, and; No subsequent surgical procedure at the index level (including revision, removal, reoperation, or supplemental fixation) by Month 60.	IDE study 24 months + PAS 36 months = 60 months total

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Neurological Status), Parent IDE Study + Post Approval Study (PAS)	Endpoint includes the number of participates in each group that had improvement in one or more radicular symptoms or myelopathy based on their Neurological Status (motor exam, sensory exam, gait exam, and reflexes) at 60 months when compared to baseline data from the prior IDE study.	IDE study 24 months + PAS 36 months = 60 months total
Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Visual Analog Scale), Parent IDE Study + Post Approval Study (PAS)	Endpoint was examined using the Visual Analog Scale (VAS) for neck and arm pain which is a straight horizontal line of fixed length (100 millimeters) oriented from zero or no pain (best) to 100mm or the worst pain ever (worst).	IDE study 24 months + PAS 36 months = 60 months total
Participants Average Disc Height, Parent IDE Study + Post Approval Study (PAS)	Disc height is calculated as a simple average of the anterior and posterior disc heights of the treated index level.	IDE study 24 months + PAS 36 months = 60 months total
Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Superior Level, Parent IDE Study + Post Approval Study (PAS)	Adjacent level disc deterioration looks at the quality of the disc space above (superior) and below (inferior) the treated index level on available radiographic images and each is graded as None, Mild, Moderate, Severe.	IDE study 24 months + PAS 36 months = 60 months total
Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Inferior Level, Parent IDE Study + Post Approval Study (PAS)	Adjacent level disc deterioration looks at the quality of the disc space above (superior) and below (inferior) the treated index level on available radiographic images and each is graded as None, Mild, Moderate, Severe.	IDE study 24 months + PAS 36 months = 60 months total
Percentage of Participants With No Displacement or Migration of the Device, Parent IDE Study + Post Approval Study (PAS)	Displacement or Migration of the device will be compared device placement at 60 months to immediate post-op data collected under the IDE study (changes of >3 mm will be considered significant)	IDE study 24 months + PAS 36 months = 60 months total
Percentage of Participants Reporting Overall Treatment Satisfaction of "Very Satisfied" or "Satisfied", Parent IDE Study + Post Approval Study (PAS)	Overall Treatment satisfaction was examined at 60 months. This was collected via a questionnaire completed by the subject. Response options to "How does the subject rate satisfaction with the treatment received?" included "Very Satisfied", "Satisfied", "Somewhat Satisfied", "Somewhat Dissatisfied", and "Very Dissatisfied". Response options to "If you could go back in time, would you choose to have the same treatment that you received for your neck condition?" included "Definitely Yes", "Probably Yes", "Maybe", "Probably Not" and "Definitely Not".	IDE study 24 months + PAS 36 months = 60 months total
Participants With Maintenance or Improvement on 12-Item Short Form Survey (SF-12), Parent IDE Study + Post Approval Study (PAS)	12-Item Short Form Survey (SF-12) is a questionnaire completed by the subject. Outcomes will be comparted at 60 months post treatment to baseline data collected from the IDE study.	IDE study 24 months + PAS 36 months = 60 months total
Percentage of Participants With No Dysphagia Handicap Index (DHI), Parent IDE Study + Post Approval Study (PAS)	Dysphagia Handicap Index (DHI) is a questionnaire completed by the subject. Outcomes at 60 months post-op were compared to baseline data collected under the IDE study.	IDE study 24 months + PAS 36 months = 60 months total

Collaborators and Investigators

• Sponsor: NuVasive

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): April 23, 2023
• Study Completion (Actual): April 23, 2023

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: P200022 PAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No