CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 380 enrolled
Drug / intervention
SECURE-C Cervical Artificial Disc +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00882661
NCT00882661N/ACompleted
CompareCT.gov

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

Globus Medical Inc·interventional·Posted Apr 16, 2009·Updated Jun 9, 2017

In Brief

A clinical study evaluating SECURE-C Cervical Artificial Disc and ASSURE Cervical plate and an allograft interbody spacer for Symptomatic Cervical Disc Disease. Completed, enrolled 380 participants.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Cervical Disc Disease
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 16, 2009
Enrollment StartJul 1, 2005
Primary CompletionApr 1, 2010
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 17.2 years ago

Interventions

SECURE-C Cervical Artificial Discdevice

Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc

ASSURE Cervical plate and an allograft interbody spacerdevice

Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion