Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-04-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04980378

Cervical Degenerative Disc Disorder

COMPLETED

Investigation of the Simplify® Cervical Artificial Disc

NCT02667067

Cervical Degenerative Disc Disease

COMPLETED NA

Investigation of the Two Level Simplify® Cervical Artificial Disc

NCT03123549

Cervical Degenerative Disc Disorder

COMPLETED NA

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

NCT05258435

Cervical Disc Disease Degenerative Disc Disease

ACTIVE_NOT_RECRUITING

SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

NCT00882661

Symptomatic Cervical Disc Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Degenerative Disc Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Simplify Disc

Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154

Group Type EXPERIMENTAL

Simplify Disc

Intervention Type DEVICE

The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.

Historical ACDF Control

Historical ACDF Data from similar protocol used as control.

Group Type OTHER

ACDF

Intervention Type OTHER

Historical ACDF control data

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simplify Disc

The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.

Intervention Type DEVICE

ACDF

Historical ACDF control data

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No