At a glance
ClinicalIndex Comparison RecordN/ACompleted· 145 enrolled
Drug / intervention
Simplify Disc +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Extended Follow-up of Investigational Device Exemption (IDE) Subjects Treated With the Simplify Cervical Artificial Disc
In Brief
A clinical study evaluating Simplify Disc and ACDF for Cervical Degenerative Disc Disorder. Completed, enrolled 145 participants across 15 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Degenerative Disc Disorder
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartJan 2021
Primary CompletionApr 2023
TodayJul 2026
First PostedNov 16, 2020
Enrollment StartJan 1, 2021
Primary CompletionApr 23, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.6 years ago
Interventions
Simplify Discdevice
The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.
ACDFother
Historical ACDF control data