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)

Study Overview

• Status: Completed
• Conditions: Ossification of Posterior Longitudinal Ligament; Intervertebral Disk Degeneration; Intervertebral Disk Displacement
• Intervention / Treatment: Device: Cervios ChronOs; Device: Bonion

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Fusion With CT(Postoperative 6 Months)	Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF).	6 months after surgery(ACDF)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS of Radiating Pain (Postoperative 6 Months)	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.	at 6 months after surgery (ACDF)
VAS of Neck Pain(Postoperative 6 Months)	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.	at 6 months after surgery (ACDF)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jin Sup Yeom, MD, PhD, Seoul National Univerity Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: June 6, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (ESTIMATE): June 8, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2014
• Last Update Submitted That Met QC Criteria: July 13, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: bone graft substitute; hydroxyapatite; anterior cervical discectomy and fusion; demineralized bone matrix; PEEK cage; b-tricalcium phosphate; Bonion; Cervios ChronOs
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Ossification, Heterotopic; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Ossification of Posterior Longitudinal Ligament
• Other Study ID Numbers: Bonion ACDF