Degenerative Disc DiseaseBONENCT04615260
Rate of Bony Fusion Using NanoBone® Synthetic Bone Graft Versus Local Autologous Bone Graft.
A study testing NanoBone in people with Degenerative Disc Disease and Spondylolisthesis, run by Artoss Inc. at 1 site in United States.
Trial summary
The objectives of this longitudinal study are to assess and measure fusion status (fused or not fused) and rate of bony fusion using NanoBone® Synthetic Bone Graft in patients requiring one to two level lumbar posterolateral fusion procedures with or without commercially available rigid spinal instrumentation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis
- What is being tested?
- NanoBone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2021to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC.
- The individual is 18 to 85 years of age.
- The individual is skeletally mature.
- The individual has been diagnosed with 1 or 2 level degenerative disc disease or spondylolisthesis grade 1-3 with or without spinal stenosis, requiring posterolateral spinal fusion surgery with bone grafting.
- The individual is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Who cannot join
- The individual has had any previous attempts at fusion, at any lumbar levels.
- The individual is morbidly obese (defined as 100 lbs over the recommended ideal weight as described in the Metropolitan Life Height and Weight Tables for Men and Women and or having a BMI >39).
- Patients with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
- Patients with systemic collagen, bone or mineralization dysfunction (such as Paget's disease, osteogenesis imperfecta, Ehlers-Danlos Syndrome).
- Patients who suffer from uncontrolled diabetes mellitus type I or insulin-dependent diabetes mellitus type II. (definition based on the glycosylated Haemoglobin level)
- Patients who are suffering from autoimmune disease.
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- Patients who previously underwent chemotherapy, immunosuppressive disease or radiation to the local area.
- Patients who received or are currently receiving corticosteroids (> 2 years > 5 mg prednisolone equivalent/d).
- Patients with active local or systemic infection.
- Patients with any known active malignancy.
- Patients with other concurrent physical or mental conditions which are likely to affect their outcome.
- Patient unable to consent for themselves
- Pregnant women
- Non-English speaking subjects. These subjects are excluded because they would not be able to complete the English-language surveys required during this study. Only English language versions of these surveys have been validated.
- Prisoners
- Patients less than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Memorial Health Care
Worcester, Massachusetts, 01605
About this study
Official title: Comparison of Fusion Success Between NanoBone Synthetic Bone Graft and Local Autogenous Bone Graft in Posterolateral Spinal Fusion
The objectives of this longitudinal study are to assess and measure fusion status (fused or not fused) and rate of bony fusion using NanoBone® Synthetic Bone Graft in patients requiring one to two level lumbar posterolateral fusion procedures with or without commercially available rigid spinal instrumentation. Our hypothesis is that the Nanobone synthetic bone graft will be as effective at creating a fusion in the lumbar spine as compared with a local bone graft. Each subject will serve as their own control during this study, as patients will receive the Nanobone graft on the right side of their spine and the local bone graft on their left side.
Read the detailed description
Subjects will be recruited for this study from among those scheduled to undergo 1-2 level posterolateral spinal fusion procedures with bone grafting for degenerative disc disease or grade 1-3 spondylolisthesis. The study will entail each subject having a local bone graft placed on the left side of their spine, with Nanobone placed on the right side of their spine during the procedure. Eligible and consenting patients recruited for this study will be subject to the standard of care. This includes the following visits: preoperative, operative, post-discharge, 4 months postoperative, 1-year postoperative, and 2-years postoperative. They will be subject to standard of care imaging modalities including AP, lateral, and flexion/extension lumbar radiographs at pre-operative, post-discharge, 4-months postoperative, 1-year postoperative, and 2-year postoperative time points. Standard of care advanced imaging including a CT scan or magnetic resonance imaging (MRI) scan will be performed pre-operatively. Patients will also receive standard of care clinical examinations and self-assessments at all clinic visits. Imaging obtained outside the standard of care for this study will include 1-year and 2-year lumbar CT scans to evaluate fusion. The 2-year lumbar CT scan will only be required if fusion has not been demonstrated at the time of the 1-year lumbar CT scan. Patients enrolled in this study who are treated with rigid pedicle screw fixation must be treated using rigid pedicle screw instrumentation appropriate for posterolateral spinal fusions.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis
- Being tested
- NanoBone
- Keywords
- Nanotechnology, NanoBone, Spine Fusion, Bone Graft
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoBoneDevice
Also called NanoHA (SiO2)
Nanobone® Synthetic Bone Graft is a nanocrystalline hydroxyapatite imbedded in a silica gel matrix. The nanocrystalline structure accurately replicates autologous hydroxyapatite and the silica gel matrix that rapidly transforms into an osteogenic matrix post-implantation. NanoBone promotes remodeling by acting as a strong osteoinductive material. NanoBone® is available as a putty.
| Study group | Role | What they receive |
|---|---|---|
| Single arm subject is own control | Other | Posterolateral fusion is bilateral, patients will receive the Nanobone graft on the right side of their spine and the local bone graft on their left side. Receives: Device: NanoBone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Fusion
Fusion will be defined as:
- Evidence of bridging trabecular bone between the transverse processes of the involved vertebral bodies
- Translational motion < 3.5mm on flexion/extension radiographs; and
- Angular motion <5 degrees on flexion/extension radiographs.
Measured: 12 months
Oswestry Disability Index (ODI) 0% lowest, no disability to 100% disabled, bedridden
Change from pre-operative score
Measured: 12 months
Secondary outcomes (2)
Visual Analog Scale (VAS) 0-no pain to 10-worst possible pain
Change from pre-operative score
Measured: 12 months
SF-36 (Short Form 36)
Change from pre-operative score
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 posted4 Nov 2020
- Study start19 Jul 2021
- Primary completion31 Dec 2024
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc 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
- Not applicable
- Intervention model
- Single group
- Model description
- Study is a prospective, non-randomized, single center clinical investigation. Each subject will serve as their own control during this study, as patients will receive the Nanobone graft on the right side of their spine and the local bone graft on their left side.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artoss Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Connelly, MD, Principal investigator, UMass Memorial Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615260
- Sponsor's protocol ID
- H0015310
- Acronym
- BONE
- Status last verified
- Feb 2025
- First submitted
- 29 Oct 2020
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fusion Success Between NanoBone Synthetic Bone Graft and Local Autogenous Bone Graft in Posterolateral Spinal Fusion
- ClinicalTrials.gov ID
- NCT04615260
- Acronym / sponsor ID
- BONE / H0015310
- Conditions
- Degenerative Disc Disease, Spondylolisthesis
- Keywords
- Nanotechnology, NanoBone, Spine Fusion, Bone Graft
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Artoss Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 4 Nov 2020 (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 objectives of this longitudinal study are to assess and measure fusion status (fused or not fused) and rate of bony fusion using NanoBone® Synthetic Bone Graft in patients requiring one to two level lumbar posterolateral fusion procedures with or without commercially available rigid spinal instrumentation. Our hypothesis is that the Nanobone synthetic bone graft will be as effective at creating a fusion in the lumbar spine as compared with a local bone graft. Each subject will serve as their own control during this study, as patients will receive the Nanobone graft on the right side of their spine and the local bone graft on their left side.
Detailed description
Subjects will be recruited for this study from among those scheduled to undergo 1-2 level posterolateral spinal fusion procedures with bone grafting for degenerative disc disease or grade 1-3 spondylolisthesis. The study will entail each subject having a local bone graft placed on the left side of their spine, with Nanobone placed on the right side of their spine during the procedure. Eligible and consenting patients recruited for this study will be subject to the standard of care. This includes the following visits: preoperative, operative, post-discharge, 4 months postoperative, 1-year postoperative, and 2-years postoperative. They will be subject to standard of care imaging modalities including AP, lateral, and flexion/extension lumbar radiographs at pre-operative, post-discharge, 4-months postoperative, 1-year postoperative, and 2-year postoperative time points. Standard of care advanced imaging including a CT scan or magnetic resonance imaging (MRI) scan will be performed pre-operatively. Patients will also receive standard of care clinical examinations and self-assessments at all clinic visits. Imaging obtained outside the standard of care for this study will include 1-year and 2-year lumbar CT scans to evaluate fusion. The 2-year lumbar CT scan will only be required if fusion has not been demonstrated at the time of the 1-year lumbar CT scan. Patients enrolled in this study who are treated with rigid pedicle screw fixation must be treated using rigid pedicle screw instrumentation appropriate for posterolateral spinal fusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study is a prospective, non-randomized, single center clinical investigation. Each subject will serve as their own control during this study, as patients will receive the Nanobone graft on the right side of their spine and the local bone graft on their left side.
| Arm | Type | Receives |
|---|---|---|
| Single arm subject is own control | Other | Device: NanoBonePosterolateral fusion is bilateral, patients will receive the Nanobone graft on the right side of their spine and the local bone graft on their left side. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC.
- The individual is 18 to 85 years of age.
- The individual is skeletally mature.
- The individual has been diagnosed with 1 or 2 level degenerative disc disease or spondylolisthesis grade 1-3 with or without spinal stenosis, requiring posterolateral spinal fusion surgery with bone grafting.
- The individual is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Key exclusion criteria (16 listed)
- The individual has had any previous attempts at fusion, at any lumbar levels.
- The individual is morbidly obese (defined as 100 lbs over the recommended ideal weight as described in the Metropolitan Life Height and Weight Tables for Men and Women and or having a BMI >39).
- Patients with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
- Patients with systemic collagen, bone or mineralization dysfunction (such as Paget's disease, osteogenesis imperfecta, Ehlers-Danlos Syndrome).
- Patients who suffer from uncontrolled diabetes mellitus type I or insulin-dependent diabetes mellitus type II. (definition based on the glycosylated Haemoglobin level)
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 |
|---|---|---|
| NanoBoneAlso: NanoHA (SiO2)Nanobone® Synthetic Bone Graft is a nanocrystalline hydroxyapatite imbedded in a silica gel matrix. The nanocrystalline structure accurately replicates autologous hydroxyapatite and the silica gel matrix that rapidly transforms into an osteogenic matrix post-implantation. NanoBone promotes remodeling by acting as a strong osteoinductive material. NanoBone® is available as a putty. | Device | Single arm subject is own control |
Primary outcome
Radiographic Fusion
Time frame: 12 months
Fusion will be defined as: * Evidence of bridging trabecular bone between the transverse processes of the involved vertebral bodies * Translational motion < 3.5mm on flexion/extension radiographs; and * Angular motion <5 degrees on flexion/extension radiographs.
Oswestry Disability Index (ODI) 0% lowest, no disability to 100% disabled, bedridden
Time frame: 12 months
Change from pre-operative score
2 secondary outcomes
Visual Analog Scale (VAS) 0-no pain to 10-worst possible pain
Time frame: 12 months
SF-36 (Short Form 36)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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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.
Patrick Connelly, MD principal investigator
UMass Memorial Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NanoBone in people with Degenerative Disc Disease and Spondylolisthesis, run by Artoss Inc. at 1 site in United States.
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 5 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Radiographic Fusion (time frame: 12 months). The study lists 2 primary outcomes in all. 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 12 Feb 2025.