CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 500 enrolled
Drug / intervention
Cervical TDR +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/NCT00432159
NCT00432159N/ACompleted
CompareCT.gov

A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease

DePuy Spine·interventional·Posted Feb 7, 2007·Updated Oct 20, 2017

In Brief

A clinical study evaluating Cervical TDR and ACDF with plate for Cervical Degenerative Disc Disease. Completed, enrolled 500 participants across 32 sites in 3 countries.

Detailed Summary

This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. Follow-up on patients treated with total disc replacement will be continued to 5 years post operative.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Degenerative Disc Disease
CountriesAustralia, Netherlands, United States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2007
Enrollment StartJul 1, 2006
Primary CompletionMay 1, 2013
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 19.4 years ago

Interventions

Cervical TDRdevice

Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.

ACDF with platedevice

Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.