Degenerative Disk DiseaseNCT01439464
Study of Bioactive Glass-ceramic Intervertebral Spacer (Bonglass-SS) in Posterior Lumbar Interbody Fusion
A study testing 4 CIS one-touch titanium cage and Bonglass-SS SSLPB in people with Degenerative Disk Disease, run by BioAlpha Inc. at 4 sites in South Korea.
Trial summary
The goal of this study is to compare Bonglass-SS with titanum cage. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Degenerative Disk Disease
- What is being tested?
- 4 CIS one-touch titanium cage and Bonglass-SS SSLPB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Oct 2010to Jun 2013
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30~80 aged patients needed single-level posterior Interbody fusion at L1~S1
- A subject who provided written informed consent to participate in this study
Who cannot join
- Patitents with BMD T-score < -3.0
- Women who are pregnant or plan to be pregnant within 3 years
- Patient with malignant tumor
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 4 recruiting
- Recruiting
Dongguk University Medical Center
Goyang-si, Gyeonggi-do
KiHyoung Koo, M.D.,Ph.D.
- Recruiting
Seoul National University Hospital
Seoul
BongSoon Chang, M.D.,Ph.D.
- Recruiting
Seoul National University Seoul Metropolitan Boramae Medical Center
Seoul
JaeHyup Lee
- Recruiting
Seoul National University Bundang Hospital
Sungnam-Si, Gyeonggi-do
KunWoo Park, M.D.,Ph.D.
About this study
Official title: Clinical Efficacy and Safety of Bioactive Glass-ceramic Intervertebral Spacer (Bonglass-SS) in Posterior Lumbar Interbody Fusion and, Titanium Cage Controlled, 1-year, Single-Blind, Non-Inferiority Trial
The goal of this study is to compare Bonglass-SS with titanum cage.
- Conditions
- Degenerative Disk Disease
- Being tested
- 4 CIS one-touch titanium cage, Bonglass-SS SSLPB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 CIS one-touch titanium cageDevice
4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd)
Bonglass-SS SSLPBDevice
Bonglass-SS SSLPB(BioAlpha Inc.)
| Study group | Role | What they receive |
|---|---|---|
| Control device | Active comparator | Not described Receives: Device: 4 CIS one-touch titanium cage |
| Investigational device | Experimental | Not described Receives: Device: Bonglass-SS SSLPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessments of fusion and instability at 12 months after surgery
Measured: 12 months
Secondary outcomes (1)
CT assessments of fusion at 12 months after surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disk DiseaseStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioAlpha Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JaeHyup Lee, M.D.,Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439464
- Sponsor's protocol ID
- BA04-CP01
- Status last verified
- Sep 2011
- First submitted
- 22 Sep 2011
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Bioactive Glass-ceramic Intervertebral Spacer (Bonglass-SS) in Posterior Lumbar Interbody Fusion and, Titanium Cage Controlled, 1-year, Single-Blind, Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT01439464
- Acronym / sponsor ID
- BA04-CP01
- Conditions
- Degenerative Disk Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- BioAlpha Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 23 Sep 2011 (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 goal of this study is to compare Bonglass-SS with titanum cage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control device | Active comparator | Device: 4 CIS one-touch titanium cage |
| Investigational device | Experimental | Device: Bonglass-SS SSLPB |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 30~80 aged patients needed single-level posterior Interbody fusion at L1~S1
- A subject who provided written informed consent to participate in this study
Key exclusion criteria (3 listed)
- Patitents with BMD T-score < -3.0
- Women who are pregnant or plan to be pregnant within 3 years
- Patient with malignant tumor
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 |
|---|---|---|
| 4 CIS one-touch titanium cage4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd) | Device | Control device |
| Bonglass-SS SSLPBBonglass-SS SSLPB(BioAlpha Inc.) | Device | Investigational device |
Primary outcome
Radiographic assessments of fusion and instability at 12 months after surgery
Time frame: 12 months
1 secondary outcome
CT assessments of fusion at 12 months after surgery
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2011.
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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.
JaeHyup Lee, M.D.,Ph.D. principal investigator
Seoul National University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 CIS one-touch titanium cage and Bonglass-SS SSLPB in people with Degenerative Disk Disease, run by BioAlpha Inc. at 4 sites 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: status not confirmed, as of the sponsor's last update on 23 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JunHyuk Seo, Ph.D. (82-31-746-5208 ext. 317, seoscy@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic assessments of fusion and instability at 12 months after surgery (time frame: 12 months). 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 Sep 2011.