Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
Condition: Intervertebral Disk Degeneration; Intervertebral Disk Displacement; Ossification of Posterior Longitudinal Ligament
MeSH terms: Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Ossification of Posterior Longitudinal Ligament
Study type: Interventional
Phase: Phase 4

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)
    

Detailed description: 
      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.
    

Intervention name(s): Cervios ChronOs; Bonion
Intervention type(s): Device; Device
Intervention description(s): The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.; The ACDF surgery will be carried out with Bonion after randomization procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: anterior cervical discectomy and fusion; bone graft substitute; PEEK cage; hydroxyapatite; demineralized bone matrix; b-tricalcium phosphate; Bonion; Cervios ChronOs