Clinical trial NCT01615328: Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
Official title: Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intervertebral Disk Degeneration
Intervertebral Disk Displacement
Ossification of Posterior Longitudinal Ligament
Keywords: anterior cervical discectomy and fusion
bone graft substitute
PEEK cage
hydroxyapatite
demineralized bone matrix
b-tricalcium phosphate
Bonion
Cervios ChronOs
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cervical HIVD, CSR, CSM or OPLL
* The patient who is expected to receive anterior cervical discectomy and fusion operation.
* Volunteer for this study with written consent.

Exclusion Criteria:

* Patient with cervical spine fracture, infection.
* Below -3.5 T-score by DEXA bone densitometry
* Patient with hemorrhagic diseases
* Patient with malignancy
* Patient who is not suitable for this study judged by principal investigator

Primary outcomes:
measure: Bone Fusion With CT(Postoperative 6 Months)
timeFrame: 6 months after surgery(ACDF)
Secondary outcomes:
measure: VAS of Radiating Pain (Postoperative 6 Months)
timeFrame: at 6 months after surgery (ACDF)
measure: VAS of Neck Pain(Postoperative 6 Months)
timeFrame: at 6 months after surgery (ACDF)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National Univerity Hospital
name: Jin Sup Yeom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: