Intervertebral Disk DegenerationPhase 4NCT01615328
Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
A Phase 4 study testing Cervios ChronOs and Bonion in people with Intervertebral Disk Degeneration and Intervertebral Disk Displacement, run by Seoul National University Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Intervertebral Disk Degeneration, Intervertebral Disk Displacement, Ossification of Posterior Longitudinal Ligament
- What is being tested?
- Cervios ChronOs and Bonion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Aug 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
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)
Read the 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
- Being tested
- Cervios ChronOs, Bonion
- Keywords
- anterior cervical discectomy and fusion, bone graft substitute, PEEK cage, hydroxyapatite, demineralized bone matrix, b-tricalcium phosphate, Bonion, Cervios ChronOs
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Ossification of Posterior Longitudinal Ligament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervios ChronOsDevice
The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.
BonionDevice
The ACDF surgery will be carried out with Bonion after randomization procedure.
| Study group | Role | What they receive |
|---|---|---|
| Cervios ChronOs | Experimental | The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP. Receives: Device: Cervios ChronOs |
| Bonion | Experimental | The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM. Receives: Device: Bonion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months after surgery(ACDF)
Secondary outcomes (2)
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.
Measured: 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.
Measured: at 6 months after surgery (ACDF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intervertebral Disk DegenerationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin S. Yeom, Seoul National University Hospital
- Investigators
- Jin Sup Yeom, MD, PhD, Principal investigator, Seoul National Univerity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615328
- Sponsor's protocol ID
- Bonion ACDF
- Status last verified
- Jul 2014
- First submitted
- 6 Jun 2012
- Last updated
- 23 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
- ClinicalTrials.gov ID
- NCT01615328
- Acronym / sponsor ID
- Bonion ACDF
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Posted 18 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervios ChronOs | Experimental | Device: Cervios ChronOsThe ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP. |
| Bonion | Experimental | Device: BonionThe ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervios ChronOsThe ACDF surgery will be carried out with Cervios ChronOs after randomization procedure. | Device | Cervios ChronOs |
| BonionThe ACDF surgery will be carried out with Bonion after randomization procedure. | Device | Bonion |
Primary outcome
Bone Fusion With CT(Postoperative 6 Months)
Time frame: 6 months after surgery(ACDF)
Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF).
2 secondary outcomes
VAS of Radiating Pain (Postoperative 6 Months)
Time frame: at 6 months after surgery (ACDF)
VAS of Neck Pain(Postoperative 6 Months)
Time frame: at 6 months after surgery (ACDF)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Sup Yeom, MD, PhD principal investigator
Seoul National Univerity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cervios ChronOs and Bonion in people with Intervertebral Disk Degeneration and Intervertebral Disk Displacement, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Fusion With CT(Postoperative 6 Months) (time frame: 6 months after surgery(ACDF)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.