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Investigation of the Simplify® Cervical Artificial Disc

Cervical Degenerative Disc Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02667067
Study type Interventional
Source NuVasive
Contact
Status Completed
Phase N/A
Start date November 2015
Completion date July 29, 2021
View Details
See also
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Completed NCT00432159 - Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study) N/A
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Recruiting NCT05880823 - Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc
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Not yet recruiting NCT05522010 - Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT N/A