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): 157

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

1

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Composite Success	Individual success for Simplify Disc is 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."	60 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically significant improvement in one or more radicular symptoms or myelopathy	Clinically significant improvement in one or more radicular symptoms or myelopathy at each annual timepoint compared to baseline in the IDE study for the two level Simplify Disc. Endpoints will be graded based on pain questionnaires, motor status, and sensory status.	60 Months
Time to recovery	Time to recovery defined as the earliest time at which a minimum 15-point (out of 100) NDI improvement is reached.	60 Months
Disc Height	Disc height at each annual timepoint compared to baseline (6 weeks) in the IDE study for the two level Simplify Disc. Both levels had to be a disc height success to claim success for overall disc height. This will be graded by the radiographic core laboratory.	60 Months
Adjacent Level Deterioration	Adjacent level deterioration at each annual timepoint compared to baseline in the investigational group of the IDE study for the two level Simplify Disc. This will be graded by the radiographic core laboratory.	60 Months
Displacement or Migration of the Device	Displacement or migration of the device will be compared to baseline in the IDE. This will be graded by the radiographic core lab.	60 Months
Work Status	Return to work status post-operatively. The subjects will be surveyed for this at each follow-up visit	60 Months
Patient Satisfaction	Patient satisfaction and perceived effect at each annual timepoint. Success will be graded via a survey response of 'Definitely True' or 'Mostly True'	60 Months
Health Survey; 36-Item Short Form Survey (SF-36)	Health Survey at each annual timepoint compared to baseline.	60 Months
Dysphagia Handicap Index (DHI scale)	Dysphagia Handicap Index (DHI scale) for the Simplify Disc at 60 months compared to baseline in the two level IDE study.	60 Months
Adjacent Level Motion (Stability)	Adjacent Level Motion (Stability) will be compared at 60 months to baseline. This will be graded by the radiographic core lab.	60 Months
Physician's Perception	Results at 60 months will be categorized by the physician's perception of the subject's condition (excellent, good, fair, or poor).	60 Months
Gait Assessment	Gait assessment at 60 months compared to baseline. This will be based on Nurick's classification. Success will be defined as maintenance or improvement in the post-operative status as compared to the pre-operative condition.	60 Months

Collaborators and Investigators

• Sponsor: NuVasive

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 (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

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