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

NCT ID: NCT01615328

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-08-31

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.

Conditions

Intervertebral Disk Degeneration; Intervertebral Disk Displacement; Ossification of Posterior Longitudinal Ligament

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cervios ChronOs

The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.

Group Type: EXPERIMENTAL

Cervios ChronOs

Intervention Type: DEVICE

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

Bonion

The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.

Group Type: EXPERIMENTAL

Bonion

Intervention Type: DEVICE

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

Interventions

Cervios ChronOs

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

Intervention Type: DEVICE

Bonion

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin S. Yeom

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Sup Yeom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National Univerity Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

Bonion ACDF

Identifier Type: -

Identifier Source: org_study_id