CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 85 enrolled
Drug / intervention
Cervios ChronOs +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/NCT01615328
NCT01615328Phase 4Completed

Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™

Seoul National University Hospital·interventional·Posted Jun 8, 2012·Updated Jul 23, 2014

In Brief

A Phase 4 clinical trial evaluating Cervios ChronOs and Bonion for Intervertebral Disk Degeneration and 2 related conditions. Completed, enrolled 85 participants across 1 site.

Detailed Summary

Anterior cervical discectomy and fusion (ACDF) has shown good treatment results for a variety of cervical spine diseases such as herniated intervertebral disc (HIVD), cervical spondylotic radiculopathy (CSR) and cervical spondylotic myelopathy (CSM). ACDF using autogenous iliac bone graft is gold standard, however, it may lead to donor-site morbidities. Preventing these complications, some authors have tried to use alterative bone graft substitutes. Among these alternatives, Cervios ChronOs™ which is the polyetheretherketone (PEEK) cage with b-tricalcium phosphate (TCP) has become popular and shown good clinical results. However, b-TCP has only osteoconduction ability of three osteogenic properties. Recently, Bonion™ which is the PEEK cage filled with hydroxyapatite (HA) / demineralized bone matrix (DBM) is introduced. HA/DBM mixture has abilities of osteoconduction and osteoinduction, therefore this alternative is expected to show superior bone fusion capability to PEEK cage with b-TCP. However, there has been no comparison study between the PEEK cage with b-TCP and the PEEK cage with HA/DBM. The purpose of this study is to evaluate bone fusion rate between these cervical spine cages using postoperative computed tomography (CT)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2012
Enrollment StartNov 1, 2011
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.1 years ago

Interventions

Cervios ChronOsdevice

The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.

Boniondevice

The ACDF surgery will be carried out with Bonion after randomization procedure.