Intervertebral Disk DegenerationNCT02425514
Evaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™
A study testing Cervios ChronOs and NovoMax™ in people with Intervertebral Disk Degeneration and Intervertebral Disk Displacement, run by BioAlpha Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®. 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
- What is being tested?
- Cervios ChronOs and NovoMax™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2015to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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 and malignant tumor
- Below -3.5 T-score by DEXA bone densitometry
- 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
Official title: Evaluation of Bone Union Following Anterior Cervical Fusion Using a Bioactive Glass-Ceramic Spacer (NovoMax™): Comparison With a PEEK Cage Filled With β-Tricalcium Phosphate (Cervios ChronOs™)
The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.
- Being tested
- Cervios ChronOs, NovoMax™
- Keywords
- Anterior cervical discectomy and fusion, NovoMax, Bioactive Glass-ceramic Intervertebral Spacer
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement
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.
NovoMax™Device
The ACDF surgery will be carried out with NovoMax™ 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 |
| NovoMax™ | Experimental | The ACDF surgery will be carried out with NovoMax™, which is the bioactive glass ceramic intervertebral spacer Receives: Device: NovoMax™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Fusion With CT and Dynamic radiographs(X-ray)(Post operative 6 Months)
Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT and X-ray at 6 months after operation (ACDF).
Measured: at 6 months after surgery (ACDF)
Secondary outcomes (1)
VAS of Neck Pain(Post operative 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 posted24 Apr 2015 (estimated)
- Study start21 May 2015
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disk DegenerationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment group: Bioactive Glass-Ceramic Spacer (NovoMax™) Active comparator: a PEEK cage Filled with β-Tricalcium Phosphate
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioAlpha Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Sup Yeom, MD. Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425514
- Sponsor's protocol ID
- BA04-CP11
- Status last verified
- Jan 2019
- First submitted
- 21 Apr 2015
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Union Following Anterior Cervical Fusion Using a Bioactive Glass-Ceramic Spacer (NovoMax™): Comparison With a PEEK Cage Filled With β-Tricalcium Phosphate (Cervios ChronOs™)
- ClinicalTrials.gov ID
- NCT02425514
- Acronym / sponsor ID
- BA04-CP11
- Keywords
- Anterior cervical discectomy and fusion, NovoMax, Bioactive Glass-ceramic Intervertebral Spacer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- BioAlpha Inc.Industry (pharma, biotech, devices)
- Study start
- 21 May 2015 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Treatment group: Bioactive Glass-Ceramic Spacer (NovoMax™) Active comparator: a PEEK cage Filled with β-Tricalcium Phosphate
| 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. |
| NovoMax™ | Experimental | Device: NovoMax™The ACDF surgery will be carried out with NovoMax™, which is the bioactive glass ceramic intervertebral spacer |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient who is expected to receive anterior cervical discectomy and fusion operation.
- Volunteer for this study with written consent.
Key exclusion criteria (3 listed)
- Patient with cervical spine fracture, infection and malignant tumor
- Below -3.5 T-score by DEXA bone densitometry
- 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 |
| NovoMax™The ACDF surgery will be carried out with NovoMax™ after randomization procedure. | Device | NovoMax™ |
Primary outcome
Bone Fusion With CT and Dynamic radiographs(X-ray)(Post operative 6 Months)
Time frame: at 6 months after surgery (ACDF)
Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT and X-ray at 6 months after operation (ACDF).
1 secondary outcome
VAS of Neck Pain(Post operative 6 Months)
Time frame: at 6 months after surgery (ACDF)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
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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. Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervios ChronOs and NovoMax™ in people with Intervertebral Disk Degeneration and Intervertebral Disk Displacement, run by BioAlpha Inc. 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 2 inclusion and 3 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 4 Jan 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and Dynamic radiographs(X-ray)(Post operative 6 Months) (time frame: at 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 4 Jan 2019.