NCT03123549

Investigation of the Two Level Simplify® Cervical Artificial Disc

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cervical Degenerative Disc Disorder

Interventions

Type	Name	Description
DEVICE	Simplify Disc	Simplify Disc at two levels of the cervical spine

Timeline

• Start date: 2017-04-01
• Primary completion: 2020-11-12
• Completion: 2022-03-24
• First posted: 2017-04-21
• Last updated: 2026-01-08
• Results posted: 2023-01-06

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study