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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jin S. Yeom, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01615328
First received: June 6, 2012
Last updated: July 13, 2014
Last verified: July 2014
  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 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)


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

Study Type: Interventional
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™

Resource links provided by NLM:


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).

    Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled "no pain (zero point)" at the far left and "greatest pain (ten point)" at the far right.


  • 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).

    Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled "no pain (zero point)" at the far left and "greatest pain (ten point)" at the far right.



Enrollment: 85
Study Start Date: November 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 carried out with Cervios ChronOs after randomization procedure.
Experimental: Bonion
The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.
Device: Bonion
The ACDF surgery will be carried out with Bonion after randomization procedure.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615328

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
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
Results First Received: September 15, 2013
Last Updated: July 13, 2014
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Intervertebral Disc 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 August 28, 2014