CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Anterior cervical discectomy and fusion (ACDF) with PEEK Cage +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/NCT01511445
NCT01511445N/ACompleted
CompareCT.gov

Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome; a Blinded Randomised Trial of Cancellous Structured Ceramic (CSC) Versus PEEK Cages.

Amedica Corporation·interventional·Posted Jan 18, 2012·Updated May 8, 2017

In Brief

A clinical study evaluating Anterior cervical discectomy and fusion (ACDF) with PEEK Cage and Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage for Radiating Pain and 2 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed Summary

This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRadiating Pain, Myelopathy, Cervicobrachial Syndrome
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 18, 2012
Enrollment StartDec 1, 2011
Primary CompletionOct 1, 2014
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.5 years ago

Interventions

Anterior cervical discectomy and fusion (ACDF) with PEEK Cagedevice

Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer

Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cagedevice

Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.