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

NuVasive

Status: Completed

Conditions: Cervical Degenerative Disc Disorder

Treatments: Device: Simplify Disc

Study type: Observational

Funder types: Industry

Identifiers

NCT04980378

P200022_S003_PAS

Details and patient eligibility

About

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

Enrollment: 291 patients

Sex: All

Volunteers: No Healthy Volunteers

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• Subjects who were withdrawn or withdrew consent to participate in the IDE study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

Trial design

291 participants in 2 patient groups

Simplify Disc

Description:

Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206

Treatment:

Device: Simplify Disc

Historical Control - Anterior Cervical Discectomy and Fusion (ACDF)

Description:

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.