Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc

Running, not enrolling

Conditions studied: Cervical Disc Disease, Degenerative Disc Disease

In brief

A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).

Key facts

Study ID

NCT05258435

Run by

NuVasive

People needed

131

Starts

2022-02-09

Expected to finish

2028-04-01

Last updated by the study team

2025-12-22

Who can join

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

You may qualify if…

• Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site
• Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study

You may not qualify if…

• Subject had an SSI at the index level during the post approval study (NCT04630626)
• Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)

Where it is running

• Hoag Orthopedics — Orange, California, United States
• The Spine Institute for Spine Restoration — Santa Monica, California, United States
• Spine Education and Research — Thornton, Colorado, United States
• Kennedy-White Orthopaedic Center — Sarasota, Florida, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Indiana Spine Group — Carmel, Indiana, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Carolina Neurosurgery and Spine Associates — Charlotte, North Carolina, United States
• Texas Spine Consultants — Addison, Texas, United States
• Texas Back Institute — Plano, Texas, United States

Full record on ClinicalTrials.gov

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