NCT00882661

SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

A Prospective Randomized Clinical Investigation of the SECURE-C Cervical Artificial Disc: A Pivotal Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Globus Medical Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the pivotal IDE clinical study was to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between C3 and C7, compared to anterior cervical discectomy and fusion. The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy associated with the use of the SECURE-C Cervical Artificial Disc

Detailed description

Ages Eligible for Study: 18 to 60 years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Conditions

• Symptomatic Cervical Disc Disease

Interventions

Type	Name	Description
DEVICE	SECURE-C Cervical Artificial Disc	Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
DEVICE	ASSURE Cervical plate and an allograft interbody spacer	Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion

Timeline

• Start date: 2005-07-01
• Primary completion: 2010-04-01
• Completion: 2017-02-01
• First posted: 2009-04-16
• Last updated: 2017-06-09
• Results posted: 2017-06-09