Investigation of the Two Level Simplify® Cervical Artificial Disc

Cervical Degenerative Disc Disorder Clinical Trial

Official title: Clinical Study Protocol for the Investigation Of The Two Level Simplify® Cervical Artificial Disc

Status Completed

Clinical Trial 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.

Clinical Trial Description

The objective of this clinical study is to evaluate the safety and effectiveness of the two-level Simplify® Disc compared to conventional two-level ACDF in skeletally mature patients for reconstruction of 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 that are unresponsive to conservative management. ;

Related Conditions & MeSH terms

• Cervical Degenerative Disc Disorder

• NCT number: NCT03123549
• Study type: Interventional
• Source: NuVasive
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Completion date: March 24, 2022