At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Study Protocol for the Investigation Of The Two Level Simplify® Cervical Artificial Disc
In Brief
A clinical study evaluating Simplify Disc for Cervical Degenerative Disc Disorder. Completed, enrolled 182 participants across 18 sites.
Detailed Summary
This study is intended to demonstrate that the Simplify® Cervical Artificial Disc (Simplify® Disc) is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces in subjects who are unresponsive to conservative management.
Study Details
Timeline
Interventions
Simplify Disc at two levels of the cervical spine