Text Size

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

This study is currently recruiting participants.
Verified May 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jin S. Yeom, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01615328
First received: June 6, 2012
Last updated: May 4, 2013
Last verified: May 2013
History of Changes
  Purpose

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)


Condition Intervention Phase
Intervertebral Disk Degeneration
Intervertebral Disk Displacement
Ossification of Posterior Longitudinal Ligament
 Device: Bonion
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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™

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 88
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervios ChronOS
The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
 Device: Bonion
Bonion(TM) is the PEEK cage filled with HA/DBM bone substitutes.
Other Name: HA/DBM filled PEEK cage

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615328

Contacts
Contact: Jin Sup Yeom, MD, PhD +82-31-787-7195 highcevical@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: MS Son            
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jin Sup Yeom, MD, PhD Seoul National Univerity Hospital
  More Information

No publications provided

Responsible Party: Jin S. Yeom, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01615328     History of Changes
Other Study ID Numbers: Bonion ACDF
Study First Received: June 6, 2012
Last Updated: May 4, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
anterior cervical discectomy and fusion
bone graft substitute
PEEK cage
hydoxyapatite
 demineralized bone matrix
b-tricalcium phosphate
Bonion
Cervios ChronOs

Additional relevant MeSH terms:
Intervertebral Disk Displacement
Intervertebral Disk Degeneration
Ossification of Posterior Longitudinal Ligament
Spinal Diseases
Bone Diseases
 Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Ossification, Heterotopic
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013