Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

NuVasive

Status

Completed

Conditions

Cervical Degenerative Disc Disorder

Treatments

Device: Simplify Disc

Other: ACDF

Study type

Interventional

Funder types

Industry

Identifiers

NCT04630626

P200022 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 Simplify Disc IDE study. This study was conducted under IDE G140154.

Full description

This post approval study (PAS) is a continuation of the IDE pivotal study (G140154) as required under P200022. These data include long-term follow-up of subjects enrolled and treated under the IDE study from February 2016 to 2018 out to 60 months post-op. The control group is comprised of a historical ACDF population. Subjects were enrolled (signed consent) into the PAS on a rolling basis at either the 36 month, 48 month or 60 month visit based on their treatment date (under IDE G140154) and the date of PAS protocol approval. Data presented are compared to baseline data collected as part of the IDE study. Therefore, the start date and end dates of the PAS are not inclusive of the full 60 months of reported data.

Enrollment

145 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

- All subjects enrolled in the 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Subjects who were withdrawn or withdrew consent to participate in the IDE study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