Degenerative Lumbar Spinal StenosisNCT03532945
A Follow-up Study to Evaluate the Efficacy and Safety of Novomax in Posterior Lumbar Interbody Fusion
A study testing Bioactive Glass-Ceramic Spacer and Titanium cage in people with Degenerative Lumbar Spinal Stenosis, run by BioAlpha Inc..
Trial summary
This is a long-term follow-up study for more than 3 years to evaluate the efficacy and safety of bioactive glass-ceramic intervertebral spacer (Novomax) in posterior lumbar interbody fusion. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis
- What is being tested?
- Bioactive Glass-Ceramic Spacer and Titanium cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 28 Oct 2010to 7 Apr 2016
- 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
- [In Interventional Study]
- Subjects who required between L1 and S1 among those who required an extensive laminectomy or facetectomy to correct severe disc extrusion or severe spinal stenosis or those who required PLIF due to grade I or II spondylolisthesis
- [In Long-term Follow-up Study]
- Subjects who are treated with bioactive glass ceramic intervertebral spacer or titanium cage in one-level PLIF surgery
Who cannot join
- [In Interventional Study]
- Subjects with average T-scores of L1-L4 at <-3.0 in DEXA bone density tests
- Subjects who are pregnant or breast-feeding
- Subjects with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study)
- Subjects with abnormal blood potassium and phosphorus levels
- Subjects who are considered not suitable for the study by significant disease(liver disease, kidney disease, respiratory disease, metabolic disease, or psychological disease)
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- Subjects who are not able to comply with the study requirements
- Subjects who are considered not suitable for the study by the investigator
- [In Long-term Follow-up Study]
- Subjects who are not able to comply with the study requirements
- Subjects who are considered not suitable for the study by the investigator
About this study
Official title: A Long-term Follow-up Study to Evaluate the Efficacy and Safety for the Patients With Bioactive Glass-ceramic Intervertebral Spacer (Novomax) in Posterior Lumbar Interbody Fusion: Comparison With a Titanium Cage
This is a long-term follow-up study for more than 3 years to evaluate the efficacy and safety of bioactive glass-ceramic intervertebral spacer (Novomax) in posterior lumbar interbody fusion.
Read the detailed description
During one-level PLIF, bioactive glass-ceramic intervertebral spacer (Novomax) and titanium cage were inserted in the experimental group and control group, respectively. Bone fusion by simple radiography had angular deformity of less than 3 degrees and a potential of less than 3 mm in flexion extension radiographs, and thin-section CT (<2 mm) was used to determine the combination between the vertebral endplate and the autogenous bone or bioactive glass-ceramic intervertebral spacer (Novomax) in the cage without any gaps or the part connected to bony trabecula as fusion, and both groups will be compared.
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Being tested
- Bioactive Glass-Ceramic Spacer, Titanium cage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive Glass-Ceramic SpacerDevice
Also called Novomax
Titanium cageDevice
| Study group | Role | What they receive |
|---|---|---|
| Bioactive Glass-Ceramic Spacer | Experimental | The one-level Posterior Lumbar Interbody Fusion(PLIF) surgery will be carried out with Novomax, which is the bioactive glass ceramic intervertebral spacer. Receives: Device: Bioactive Glass-Ceramic Spacer |
| Titanium cage | Active comparator | The one-level Posterior Lumbar Interbody Fusion(PLIF) surgery will be carried out with titanium cage. Receives: Device: Titanium cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone fusion with radiographs (X-ray)
Evaluation of bone fusion between bone substitutes and vertebral endplates with X-ray for 36 months(or more than 36 months) after PLIF surgery.
Measured: for 36 months after surgery
Secondary outcomes (5)
Bone fusion with 3-dimensional computed tomography(CT)
Evaluation of bone fusion between bone substitutes and vertebral endplates with 3-dimensional CT for 36 months(or more than 36 months) after PLIF surgery.
Measured: for 36 months after surgery
The Oswestry Disability Index(ODI) assessment
Evaluation of the Oswestry disability index questionnaire survey for 36 months(or more than 36 months) after PLIF surgery.
Measured: for 36 months after surgery
The SF(Short Form)-36 questionnaire assessment
Evaluation of the SF(Short Form)-36 questionnaire survey for 36 months(or more than 36 months) after PLIF surgery.
Measured: for 36 months after surgery
VAS for target site
Evaluation of target site pain using the visual analogue scale (VAS) for 36 months(or more than 36 months) after PLIF surgery.
Measured: for 36 months after surgery
1.Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Evaluation of AE
Measured: for 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start28 Oct 2010
- Primary completion13 Sep 2013
- Study completion7 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spinal StenosisStudies 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
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioAlpha Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bong-Soon Chang, MD. PhD., Principal investigator, Seoul National University HospitalKi Hyoung Koo, MD. PhD., Principal investigator, DongGuk UniversityHo-Joong Kim, MD. PhD., Principal investigator, Seoul National University Bundang HospitalJae Hyup Lee, MD. PhD., Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532945
- Sponsor's protocol ID
- B1504
- Status last verified
- May 2018
- First submitted
- 2 May 2018
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Follow-up Study to Evaluate the Efficacy and Safety for the Patients With Bioactive Glass-ceramic Intervertebral Spacer (Novomax) in Posterior Lumbar Interbody Fusion: Comparison With a Titanium Cage
- ClinicalTrials.gov ID
- NCT03532945
- Acronym / sponsor ID
- B1504
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- BioAlpha Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2010 (actual)
- Primary completion
- 13 Sep 2013 (actual)
- Study completion
- 7 Apr 2016 (actual)
- First posted
- 22 May 2018 (actual)
- 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.
This is a long-term follow-up study for more than 3 years to evaluate the efficacy and safety of bioactive glass-ceramic intervertebral spacer (Novomax) in posterior lumbar interbody fusion.
Detailed description
During one-level PLIF, bioactive glass-ceramic intervertebral spacer (Novomax) and titanium cage were inserted in the experimental group and control group, respectively. Bone fusion by simple radiography had angular deformity of less than 3 degrees and a potential of less than 3 mm in flexion extension radiographs, and thin-section CT (<2 mm) was used to determine the combination between the vertebral endplate and the autogenous bone or bioactive glass-ceramic intervertebral spacer (Novomax) in the cage without any gaps or the part connected to bony trabecula as fusion, and both groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive Glass-Ceramic Spacer | Experimental | Device: Bioactive Glass-Ceramic SpacerThe one-level Posterior Lumbar Interbody Fusion(PLIF) surgery will be carried out with Novomax, which is the bioactive glass ceramic intervertebral spacer. |
| Titanium cage | Active comparator | Device: Titanium cageThe one-level Posterior Lumbar Interbody Fusion(PLIF) surgery will be carried out with titanium cage. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- [In Interventional Study]
- Subjects who required between L1 and S1 among those who required an extensive laminectomy or facetectomy to correct severe disc extrusion or severe spinal stenosis or those who required PLIF due to grade I or II spondylolisthesis
- [In Long-term Follow-up Study]
- Subjects who are treated with bioactive glass ceramic intervertebral spacer or titanium cage in one-level PLIF surgery
Key exclusion criteria (11 listed)
- [In Interventional Study]
- Subjects with average T-scores of L1-L4 at <-3.0 in DEXA bone density tests
- Subjects who are pregnant or breast-feeding
- Subjects with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study)
- Subjects with abnormal blood potassium and phosphorus levels
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 |
|---|---|---|
| Bioactive Glass-Ceramic SpacerAlso: Novomax | Device | Bioactive Glass-Ceramic Spacer |
| Titanium cage | Device | Titanium cage |
Primary outcome
Bone fusion with radiographs (X-ray)
Time frame: for 36 months after surgery
Evaluation of bone fusion between bone substitutes and vertebral endplates with X-ray for 36 months(or more than 36 months) after PLIF surgery.
5 secondary outcomes
Bone fusion with 3-dimensional computed tomography(CT)
Time frame: for 36 months after surgery
The Oswestry Disability Index(ODI) assessment
Time frame: for 36 months after surgery
The SF(Short Form)-36 questionnaire assessment
Time frame: for 36 months after surgery
VAS for target site
Time frame: for 36 months after surgery
1.Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: for 36 months after surgery
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 22 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Bong-Soon Chang, MD. PhD. principal investigator
Seoul National University Hospital
Ki Hyoung Koo, MD. PhD. principal investigator
DongGuk University
Ho-Joong Kim, MD. PhD. principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Bioactive Glass-Ceramic Spacer and Titanium cage in people with Degenerative Lumbar Spinal Stenosis, run by BioAlpha Inc..
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 4 inclusion and 11 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 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 radiographs (X-ray) (time frame: for 36 months after surgery). 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 22 May 2018.