At a glance
ClinicalIndex Comparison RecordN/ACompleted· 291 enrolled
Drug / intervention
Simplify Discdevice
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.
Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc
In Brief
An observational study evaluating Simplify Disc for Cervical Degenerative Disc Disorder. Completed, enrolled 291 participants across 18 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 two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Degenerative Disc Disorder
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartAug 2021
Primary CompletionJan 2024
TodayJul 2026
First PostedJul 28, 2021
Enrollment StartAug 1, 2021
Primary CompletionJan 24, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.9 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.