NCT02667067

Investigation of the Simplify® Cervical Artificial Disc

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to demonstrate that the Simplify® Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space 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 Simplify® Disc for treatment of DDD compared to conventional ACDF for reconstruction of the disc space at one level between C3 to C7 for DDD defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space that is unresponsive to conservative management.

Conditions

• Cervical Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	Simplify Disc	Simplify Disc at one level in the cervical spine.
DEVICE	Anterior Cervical Discectomy & Fusion	This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\|C Disc trial.

Timeline

• Start date: 2015-11-01
• Primary completion: 2020-03-23
• Completion: 2021-07-29
• First posted: 2016-01-28
• Last updated: 2026-01-08
• Results posted: 2022-06-06

Locations

16 sites across 1 country: United States