Degenerative Lumbar Spinal StenosisNovomaxNCT03302520
Comparison of Bioactive Glass Ceramics Spacer and PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, RCT
A study testing NovoMax, BioAlpha Inc, Seong-nam, Korea and PEEK cage in people with Degenerative Lumbar Spinal Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The authors aimed to compare the clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass ceramics with PEEK cage that is widely used for posterior lumbar interbody fusion (PLIF) surgery in the clinical field. 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?
- NovoMax, BioAlpha Inc, Seong-nam, Korea and PEEK cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Oct 2017to 30 Aug 2020
- 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
- patients aged between 30 and 80
- patients who required one-level PLIF 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
- those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form.
Who cannot join
- osteoporosis patients with average T-scores of L1-L4 at <-3.0 in DEXA bone density tests
- women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years
- patients 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)
- patients with abnormal blood potassium and phosphorus levels;
- patients with liver disease, kidney disease, respiratory disease, metabolic disease, or psychological disease;
- patients deemed to have less than 1-year life expectancy;
- patients with mental retardation or whose parents or legal guardians were older or had mental disabilities;
- other patients viewed as inappropriate by the staff
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyounggido
About this study
Official title: Comparison of Fusion Rate and Clinical Results Between Bioactive Glass Ceramics Spacer With PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, Randomized Controlled Non-inferiority Trial
The authors aimed to compare the clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass ceramics with PEEK cage that is widely used for posterior lumbar interbody fusion (PLIF) surgery in the clinical field.
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Being tested
- NovoMax, BioAlpha Inc, Seong-nam, Korea, PEEK cage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoMax, BioAlpha Inc, Seong-nam, KoreaDevice
CaO-SiO2-P2O5-B2O3 glass ceramics spacer
PEEK cageDevice
PEEK cage
| Study group | Role | What they receive |
|---|---|---|
| Novomax | Experimental | Novomax(R) ceramic glass spacer for interbody fusion Receives: Device: NovoMax, BioAlpha Inc, Seong-nam, Korea |
| PEEK cage | Active comparator | PEEK cage for interbody fusion Receives: Device: PEEK cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion rates
This is assessed by postoperative computed tomography at 1 year after surgery
Measured: up to 5 year after operation
Secondary outcomes (6)
Visual Analog Pain Scale (VAS)
VAS is a measurement score that indicates pain severity status. VAS score comprised a 10-cm line with ''none'' (0) on one end of the scale and ''disabling pain'' (10) on the other.
Measured: 3, 6, and 12, months, and every year, up to 5 year after operation
Oswestry Disability Index (ODI)
The ODI is based on a self-administered questionnaire measuring ''back-specific function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale.20 The ODI scores ranges from 0 to 100, with higher scores indicating severe symptoms.
Measured: 3, 6, and 12, months, and every year, up to 5 year after operation
EQ-5D
EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.
Measured: 3, 6, and 12, months, and every year, up to 5 year after operation
PainDETECT
The painDETECT Questionnaire (PDQ) is a screening tool designed to detect neuropathic pain in patients with chronic low back pain (LBP) based on self-reported pain characteristics. The degree of the seven types of pain quality, the type of pain pattern, and the presence of radiating pain. From the three components of the PDQ, a total score is calculated; a high score indicates that the pain is likely to have a neuropathic component. Scoring is performed using a scoring manual, and results in a final screening score: a score of 0-12 indicates nociceptive pain, 19-38 indicates neuropathic pain, and 13-18 indicates mixed pain.
Measured: 3, 6, and 12, months, and every year, up to 5 year after operation
Fusion rates
This is assessed by postoperative simple radiography at 1 year after surgery
Measured: every year, up to 5 year after operation
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Device related adverse events (fracture, translation, subsidence, osteolysis), Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)
Measured: every year, up to 5 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start28 Oct 2017
- Primary completion11 Jul 2019
- Study completion30 Aug 2020
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302520
- Sponsor's protocol ID
- Nvmax_001
- Acronym
- Novomax
- Status last verified
- Mar 2022
- First submitted
- 21 Sep 2017
- Last updated
- 23 Mar 2022
- 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 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fusion Rate and Clinical Results Between Bioactive Glass Ceramics Spacer With PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT03302520
- Acronym / sponsor ID
- Novomax / Nvmax_001
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Oct 2017 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 5 Oct 2017 (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.
The authors aimed to compare the clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass ceramics with PEEK cage that is widely used for posterior lumbar interbody fusion (PLIF) surgery in the clinical field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novomax | Experimental | Device: NovoMax, BioAlpha Inc, Seong-nam, KoreaNovomax(R) ceramic glass spacer for interbody fusion |
| PEEK cage | Active comparator | Device: PEEK cagePEEK cage for interbody fusion |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged between 30 and 80
- patients who required one-level PLIF 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
- those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form.
Key exclusion criteria (8 listed)
- osteoporosis patients with average T-scores of L1-L4 at <-3.0 in DEXA bone density tests
- women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years
- patients 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)
- patients with abnormal blood potassium and phosphorus levels;
- patients with liver disease, kidney disease, respiratory disease, metabolic disease, or psychological disease;
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 |
|---|---|---|
| NovoMax, BioAlpha Inc, Seong-nam, KoreaCaO-SiO2-P2O5-B2O3 glass ceramics spacer | Device | Novomax |
| PEEK cagePEEK cage | Device | PEEK cage |
Primary outcome
Fusion rates
Time frame: up to 5 year after operation
This is assessed by postoperative computed tomography at 1 year after surgery
6 secondary outcomes
Visual Analog Pain Scale (VAS)
Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
Oswestry Disability Index (ODI)
Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
EQ-5D
Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
PainDETECT
Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
Fusion rates
Time frame: every year, up to 5 year after operation
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: every year, up to 5 year after operation
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 23 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NovoMax, BioAlpha Inc, Seong-nam, Korea and PEEK cage in people with Degenerative Lumbar Spinal Stenosis, 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 8 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 Mar 2022. 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?
Fusion rates (time frame: up to 5 year after operation). 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 Mar 2022.