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

Completed

Conditions studied: Cervical Degenerative Disc Disorder

In brief

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

Key facts

Study ID

NCT04980378

Run by

NuVasive

People needed

291

Starts

2021-08-01

Expected to finish

2024-01-24

Last updated by the study team

2026-01-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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• Subjects who were withdrawn or withdrew consent to participate in the IDE study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

Where it is running

• Orthopaedic Education and Research Institute of Southern California — Orange, California, United States
• The Spine Institute for Spine Restoration — Santa Monica, California, United States
• Spine Education and Research Foundation — Thornton, Colorado, United States
• Connecticut Orthopaedic Specialists — Hamden, Connecticut, United States
• Kennedy-White Orthopedic Center — Sarasota, Florida, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Indiana Spine Group — Carmel, Indiana, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• Orthopaedic Institute of Western Kentucky — Paducah, Kentucky, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• William Beaumont Hospital Research Institute — Royal Oak, Michigan, United States
• Buffalo Spine Surgery — Lockport, New York, United States
• Carolina Neurosurgery and Spine Associates — Charlotte, North Carolina, United States
• Oregon Neurosurgery — Springfield, Oregon, United States
• Texas Spine Consultants — Addison, Texas, United States
• Texas Back Institute — Plano, Texas, United States
• The Disc Replacement Center — West Jordan, Utah, United States
• Virginia Spine Institute — Reston, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.