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OpenTrials
Completed

NCT Number: NCT01615328

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)

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Key information

Conditions

Intervertebral Disk Degeneration Bone Diseases Hernia Intervertebral Disc Degeneration Intervertebral Disc Displacement Intervertebral Disk Displacement Musculoskeletal Diseases Ossification of Posterior Longitudinal Ligament Ossification, Heterotopic Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervios ChronOs

Device

The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.

Bonion

Device

The ACDF surgery will be carried out with Bonion after randomization procedure.

Primary outcomes

  1. Bone Fusion With CT(Postoperative 6 Months)

    Time frame: 6 months after surgery(ACDF)

    Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF).

Secondary outcomes

  1. VAS of Radiating Pain (Postoperative 6 Months)

    Time frame: at 6 months after surgery (ACDF)

    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.

  2. VAS of Neck Pain(Postoperative 6 Months)

    Time frame: at 6 months after surgery (ACDF)

    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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 8, 2012
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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