Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
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 polyetherethereketone (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)
Intervertebral Disk Degeneration
Intervertebral Disk Displacement
Ossification of Posterior Longitudinal Ligament
Device: Cervios ChronOs
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™|
- Bone Fusion With CT(Postoperative 6 Months) [ Time Frame: 6 months after surgery(ACDF) ] [ Designated as safety issue: No ]Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF).
- VAS of Radiating Pain (Postoperative 6 Months) [ Time Frame: at 6 months after surgery (ACDF) ] [ Designated as safety issue: No ]Evaluation of radiating pain using the visual analogue scale (VAS) at 6 months after operation (ACDF).
- VAS of Neck Pain(Postoperative 6 Months) [ Time Frame: at 6 months after surgery (ACDF) ] [ Designated as safety issue: No ]Evaluation of neck pain using the visual analogue scale (VAS) at 6 months after operation (ACDF).
|Study Start Date:||November 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Cervios ChronOs
The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.
Device: Cervios ChronOs
The ACDF surgery will be caried out with Cervios ChronOs after randomization procedure.
The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.
The ACDF surgery will be caried out with Bonion after randomization procedure.
Biologically, graft material should be endowed with several basic properties. Several synthetic materials and graft substitues have been developed to maximize fusion outcomes while avoiding complications of havesting autograft. Mixture of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), have been widely utilized for bony regeneration. On the other hand, demineralized bone matrix (DBM) has been utilized as a graft substitute with mainly its osteoinductive ability. While HA and β-TCP have osteoinductive osteoconductive properties and DBM has osteoconductive osteoinductive properties, a graft material fully incorporating both properties has not been developed. We hypothesize that an interbody graft material equipped simultaneously with osteoinductivity and osteoconductivity would enhance fusion achievement; however, clinical trials with mixture materials within a PEEK cage in ACDF surgery have rarely been performed.
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707|
|Principal Investigator:||Jin Sup Yeom, MD, PhD||Seoul National Univerity Hospital|