Intervertebral Disk Displacement Clinical Trial
Official title:
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
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)
Biologically, graft material should be endowed with several basic properties. Several synthetic materials and graft substitutes have been developed to maximize fusion outcomes while avoiding complications of harvesting 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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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