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

NCT01615328 | Completed Phase 4 Results DMC

• 1 other identifier: Bonion ACDF
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Keywords

anterior cervical discectomy and fusion; bone graft substitute; PEEK cage; hydroxyapatite; demineralized bone matrix; b-tricalcium phosphate; Bonion; Cervios ChronOs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• VAS of Radiating Pain (Postoperative 6 Months)

  at 6 months after surgery (ACDF)

• VAS of Neck Pain(Postoperative 6 Months)

  at 6 months after surgery (ACDF)

Study Arms (2)

Cervios ChronOs

EXPERIMENTAL

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

Device: Cervios ChronOs

Bonion

EXPERIMENTAL

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

Device: Bonion

Interventions

Cervios ChronOs DEVICE

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

Cervios ChronOs

Bonion DEVICE

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

Bonion

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ossification, Heterotopic; Pathologic Processes

Limitations and Caveats

Our study was included relatively small samples and short follow-up periods with 77 patients and one year duration. the measurement bias could be presented by individually different extent of neck flexion and extension in dynamic radiographs.

Results Point of Contact

• Title: Jin-Sup Yeom
• Organization: Seoul National University Bundang Hospital

highcervical@gmail.com

82-31-787-7190

Study Officials

• Jin Sup Yeom, MD, PhD

  Seoul National Univerity Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: November 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 23, 2014
• Results First Posted: November 18, 2013

Record last verified: 2014-07

Locations

KR (1)