Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

NCT04630626 | Completed Results FDA Device

• 1 other identifier: P200022 PAS
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Cervical Degenerative Disc Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Number of Participants With Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Neurological Status), Parent IDE Study + Post Approval Study (PAS)

  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)

  IDE study 24 months + PAS 36 months = 60 months total

• Participants Average Disc Height, Parent IDE Study + Post Approval Study (PAS)

  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)

  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)

  IDE study 24 months + PAS 36 months = 60 months total

Study Arms (2)

Simplify Disc

EXPERIMENTAL

Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154

Device: Simplify Disc

Historical ACDF Control

OTHER

Historical ACDF Data from similar protocol used as control.

Other: ACDF

Interventions

Simplify Disc DEVICE

The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.

Simplify Disc

ACDF OTHER

Historical ACDF control data

Historical ACDF Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NuVasive: lead

Study Sites (15)

Orthopaedic Education and Research Institute of Southern California

Orange, California, 92868, United States

Location

USCD

San Diego, California, 92121, United States

Location

The Spine Institute for Spine Restoration

Santa Monica, California, 90403, United States

Location

Spine Education and Research Foundation

Thornton, Colorado, 80229, United States

Location

Kennedy-White orthopedic Center

Sarasota, Florida, 34232, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42003, United States

Location

Spine institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Rothman Institute

Egg Harbor, New Jersey, 08234, United States

Location

Buffalo Spine Surgery

Lockport, New York, 14094, United States

Location

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28204, United States

Location

Texas Spine Consultants

Addison, Texas, 75001, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

Virginia Spine Institute

Reston, Virginia, 20191, United States

Location

Limitations and Caveats

Limited radiographic and neurological data for historical ACDF control group.

Results Point of Contact

• Title: Nicole Czaplewski, Manager Clinical Affairs
• Organization: NuVasive, Inc.

nczaplewski@nuvasive.com

308-660-2021

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 16, 2020
• Study Start: January 1, 2021
• Primary Completion: April 23, 2023
• Study Completion: April 23, 2023
• Last Updated: January 8, 2026
• Results First Posted: May 30, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)