Phase 4
N=85
Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
Intervertebral Disk Degeneration · Intervertebral Disk Displacement · Ossification of Posterior Longitudinal Ligament
Bottom Line
View on ClinicalTrials.gov: NCT01615328 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Bone Fusion With CT(Postoperative 6 Months) — 26; 28 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cervios ChronOs (Device); Bonion (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Fusion With CT(Postoperative 6 Months) |
26; 28 | — |
| SECONDARY VAS of Radiating Pain (Postoperative 6 Months) |
2.4; 2.9 | — |
| SECONDARY VAS of Neck Pain(Postoperative 6 Months) |
2.3; 2.0 | — |
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)
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
Data sourced from ClinicalTrials.gov (NCT01615328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.