Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc

NCT04980378 | Completed Results FDA Device

• 1 other identifier: P200022_S003_PAS
• Study Type: observational
• Target: 291
• Locations: 1 country
• Sites: 18

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 two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206

Conditions

Cervical Degenerative Disc Disorder

Keywords

Two Level

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Clinically Significant Improvement in One or More Radicular Symptoms or Myelopathy

  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

  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

  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

• Dysphagia Handicap Index (DHI Scale)

  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.

• Patient Satisfaction

  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

Study Arms (2)

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

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.

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

Eligibility Criteria

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

You may qualify if:

• \- All subjects enrolled in the two level 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 (18)

Orthopaedic Education and Research Institute of Southern California

Orange, California, 92868, 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

Connecticut Orthopaedic Specialists

Hamden, Connecticut, 06518, 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

Parkview Research Center

Fort Wayne, Indiana, 46845, United States

Location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42003, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

William Beaumont Hospital Research Institute

Royal Oak, Michigan, 48073, 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

Oregon Neurosurgery

Springfield, Oregon, 97477, United States

Location

Texas Spine Consultants

Addison, Texas, 75001, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

The Disc Replacement Center

West Jordan, Utah, 84088, United States

Location

Virginia Spine Institute

Reston, Virginia, 20191, United States

Location

Results Point of Contact

• Title: Jessica Fulwider, Lead Clinical Project Manager
• Organization: Globus Medical

jfulwider@globusmedical.com

703-772-1455

Study Officials

• Kyle Malone

  Globus Medical

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 28, 2021
• Study Start: August 1, 2021
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: January 8, 2026
• Results First Posted: March 26, 2025

Record last verified: 2025-12

Locations

US (18)