Degenerative Disc DiseasePhase 4NCT03751943
NanoFUSE® PL Gutter PMCF
A Phase 4 study testing NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) in people with Degenerative Disc Disease, run by NanoFUSE Biologics, LLC.
Trial summary
This study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal fusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Mar 2021
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade I or II (less than 50% slip f the cephalic vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L5
- Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of nonsurgical treatment, or such patients with worsening neurological condition
- Patients who are medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix is consistent with product labeling
- Patients who have consented for surgical treatment
- Patients able to provide informed consent for the study and complete the questionnaires
Who cannot join
- Lytic spondylolisthesis
- Non degenerative stenosis (example: tumor, trauma, epidural, lipomatosis)
- Segmental kyphosis at the level of the spondylolisthesis
- Rheumatoid arthritis
- Active infection
- On long term disability or workers compensation claim
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Investigation of NanoFUSE® Bioactive Matrix and Autogenous Bone in Posterolateral Spinal Fusion (Nonloadbearing)
This study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal fusion.
Read the detailed description
NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis.) These defects may be surgically created osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine. This product provides a bone graft substitute that remodels into the recipient's skeletal system. Radiographic success will be the primary judgement of success. All patient's achieving fused or probably fused status will be judged as a success.
- Conditions
- Degenerative Disc Disease
- Being tested
- NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)
- Keywords
- Demineralized Bone Matrix, Primary Lumbar Fusion, Autograft Lumbar Fusion
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)Device
NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter
| Study group | Role | What they receive |
|---|---|---|
| NanoFuse® PL Gutter | Other | NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) within one posterolateral gutter (unilateral) Receives: Device: NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Success
All patients achieving fused or probably fused status will be judged as successes at 12 months.
Measured: 12 months
Secondary outcomes (1)
Overall patient success
Overall patient success will be based on all clinical and radiographic evaluation parameters and complications for the indication for use.
Success criteria includes the following:
- Presence of radiographic fusion as evidenced by identification of new bone mass
- No hardware failure or screw blackout
- Decreased level of pain (VAS)
- Maintained or improved level of function (ODI)
- Maintained or improved neurological status
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study startJan 2019 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NanoFUSE Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751943
- Sponsor's protocol ID
- CPR-00001
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of NanoFUSE® Bioactive Matrix and Autogenous Bone in Posterolateral Spinal Fusion (Nonloadbearing)
- ClinicalTrials.gov ID
- NCT03751943
- Acronym / sponsor ID
- CPR-00001
- Conditions
- Degenerative Disc Disease
- Keywords
- Demineralized Bone Matrix, Primary Lumbar Fusion, Autograft Lumbar Fusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NanoFUSE Biologics, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2019 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 23 Nov 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 study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal fusion.
Detailed description
NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis.) These defects may be surgically created osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine. This product provides a bone graft substitute that remodels into the recipient's skeletal system. Radiographic success will be the primary judgement of success. All patient's achieving fused or probably fused status will be judged as a success.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NanoFuse® PL Gutter | Other | Device: NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) within one posterolateral gutter (unilateral) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Grade I or II (less than 50% slip f the cephalic vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L5
- Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of nonsurgical treatment, or such patients with worsening neurological condition
- Patients who are medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix is consistent with product labeling
- Patients who have consented for surgical treatment
- Patients able to provide informed consent for the study and complete the questionnaires
Key exclusion criteria (6 listed)
- Lytic spondylolisthesis
- Non degenerative stenosis (example: tumor, trauma, epidural, lipomatosis)
- Segmental kyphosis at the level of the spondylolisthesis
- Rheumatoid arthritis
- Active infection
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 |
|---|---|---|
| NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter | Device | NanoFuse® PL Gutter |
Primary outcome
Radiographic Success
Time frame: 12 months
All patients achieving fused or probably fused status will be judged as successes at 12 months.
1 secondary outcome
Overall patient success
Time frame: 12 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) in people with Degenerative Disc Disease, run by NanoFUSE Biologics, LLC.
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 6 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 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Holly Cole (978-358-7307 ext. 1004, hollycole@rqmis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Success (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 Nov 2018.