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

Intervertebral Disk Displacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615328
• Other study ID #: Bonion ACDF
• Status: Completed
• Phase: Phase 4
• First received: June 6, 2012
• Last updated: July 13, 2014
• Start date: November 2011
• Est. completion date: August 2013

Study information

• Verified date: July 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Intervertebral Disk Degeneration
• Intervertebral Disk Displacement
• Ossification of Posterior Longitudinal Ligament

Intervention

Device:
• Cervios ChronOs
The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.
• Bonion
The ACDF surgery will be carried out with Bonion after randomization procedure.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No