Post Approval Study Protocol for the Two Level 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 two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 291

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Orthopaedic Education and Research Institute of Southern California
    • Santa Monica, California, United States, 90403
      • The Spine Institute for Spine Restoration
  • Colorado
    • Thornton, Colorado, United States, 80229
      • Spine Education and Research Foundation
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Connecticut Orthopaedic Specialists
  • 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
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Orthopaedic Institute of Western Kentucky
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Spine Institute of Louisiana
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital Research 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
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Oregon Neurosurgery
  • Texas
    • Addison, Texas, United States, 75001
      • Texas Spine Consultants
    • Plano, Texas, United States, 75093
      • Texas Back Institute
  • Utah
    • West Jordan, Utah, United States, 84088
      • The Disc Replacement Center
  • 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

• Sampling Method: Non-Probability Sample

Study Population

The study population will include subjects who were enrolled in the IDE study G150206. This will include up to 170 subjects eligible for study enrollment from sixteen (16) sites in the two level Simplify Disc IDE study who consent to long-term follow-up. Additionally, up to 17 training subjects from the two level Simplify Disc IDE study from seventeen (17) sites will be enrolled.

Description

Inclusion Criteria:

- All subjects enrolled in the two level 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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Simplify Disc; Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Composite Success	Individual success for Simplify Disc was defined as follows: Neck Disability Index (NDI) score improvement of at least 15 points from pre-operative;; Maintenance or improvement in neurological status;; No serious adverse event classified as implant associated or implant/surgical procedure associated; and; No additional surgical procedure classified as a "failure."	Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysphagia Handicap Index (DHI Scale)	Dysphagia Handicap Index score for the Simplify Disc subjects at 60 months. A higher score is indicative of a less desirable outcome. It is scored 0-100. Data was not collected on DHI in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.	Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
Change in Average Disc Height (Superior Index Level)	Average disc height (superior index level) at 60 months was compared to the baseline measurement in the IDE study and the change was calculated. Measurements were scored by an independent core lab. Average disc height was calculated as the simple average of the anterior and posterior disc heights. Data was not collected on average disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.	Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
Change in Average Disc Height (Inferior Index Level)	Average disc height (inferior index level) at 60 months was compared to the baseline measurement in the IDE study and the change was calculated. Measurements were scored by an independent core lab. Average disc height was calculated as the simple average of the anterior and posterior disc heights. Data was not collected on average disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.	Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
Adjacent Level Deterioration - Superior Adjacent Level	Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), or severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space). Assessments were made by an independent core lab. Data was not collected on adjacent level deterioration in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.	Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
Adjacent Level Deterioration - Inferior Adjacent Level	Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), or severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space). Assessments were made by an independent core lab. Data was not collected on adjacent level deterioration in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.	Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
Clinically Significant Improvement in One or More Radicular Symptoms or Myelopathy	An arm pain questionnaire was used to measure radicular symptoms and compare to baseline symptoms in the IDE study. Changes of at least 2 points on a 10-point scale were regarded as clinically significant (0=no pain; 10=worst pain)	Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or Improvement	The PCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related quality-of-life. Higher scores indicate better outcomes. Scores range from 0-50. Maintenance or improvement was defined as PCS(Postop) - PCS(Preop) ≥0.	Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or Improvement	The MCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related quality-of-life. Higher scores indicate better outcomes. Scores range from 0-50. Maintenance or improvement was defined as PCS(Postop) - PCS(Preop) ≥0.	Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
Patient Satisfaction	Patient satisfaction was assessed by survey based on the response to the statement "I am satisfied with the results of my surgery" at 60 months. Answer options ranged from definitely true to definitely false.	Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
Physician's Perception	Results at 60 months were categorized by the physician's perception of the subject's condition (excellent, good, fair, or poor).	Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
Displacement or Migration of the Device	Displacement or migration of the device at 60 months was be compared to immediate post-op data collected in the IDE study. This was be graded by the radiographic core lab. Migration was considered "present" if changes of >3mm were noted. The superior index level and inferior index level was assessed separately.	Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported

Collaborators and Investigators

• Sponsor: NuVasive
• Investigators: Study Director: Kyle Malone, Globus Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): January 24, 2024
• Study Completion (Actual): January 24, 2024

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 28, 2021

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

• Keywords: Two Level
• Other Study ID Numbers: P200022_S003_PAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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