Bone; DegenerationPhase 4NCT03762811
Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix
A Phase 4 study testing NanoFUSE® Bioactive Matrix in people with Bone; Degeneration, run by NanoFUSE Biologics, LLC.
Trial summary
This purpose of this study is to determine fusion rates and compare clinical outcomes of the NanoFUSE® Bioactive Matrix during post-market clinical use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone; Degeneration
- What is being tested?
- NanoFUSE® Bioactive Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 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
- Skeletally mature
- Medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix consistent with product labeling
- Psychosocially, mentally, and physically able to fully comply with the protocol, including the post-operative regimen, requires follow-up visits, filling out required forms, and the ability to understand and give written informed consent
- Retrospective data collection must be allowed by the IRB and all information deidentified
Who cannot join
- Previous fusion surgery of the proposed site
- Use of chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day)
- Pregnant or female intending to become pregnant during this study period
- Obesity (BMI >40kg/m2)
- Systemic infection or infection at the surgical site
- Current or past substance abuse
- Poor general healthy or any concurrent disease process that would place the patient in excessive risk to surgery (e.g. significant circulatory or pulmonary problems, cardiac disease
- Medical condition that would interfere with post-operative assessments and care
Trial locations and contacts
No sites are listed yet.
About this study
This purpose of this study is to determine fusion rates and compare clinical outcomes of the NanoFUSE® Bioactive Matrix during post-market clinical use.
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 or osseous defects created from traumatic injury to bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. This product provides a bone graft substitute that remodels into the recipient's skeletal system.
- Conditions
- Bone; Degeneration
- Being tested
- NanoFUSE® Bioactive Matrix
- Keywords
- Demineralized Bone Matrix, Bone Graft, Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoFUSE® Bioactive MatrixDevice
NanoFUSE® is placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.
| Study group | Role | What they receive |
|---|---|---|
| NanoFUSE® PMCF | Other | NanoFUSE® Bioactive Matrix will be implanted according to labeling and the intended surgical treatment plan of the surgeon. Receives: Device: NanoFUSE® Bioactive Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Success that indicates patient achieving fused or probably fused status.
at 12 months
Measured: 12 months
Secondary outcomes (1)
Overall patient success
Overall patient success will be based on all clinical and radiographic evaluation
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 posted4 Dec 2018
- Study startFeb 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 Bone; DegenerationStudies 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
- 100 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
- NCT03762811
- Sponsor's protocol ID
- CPR-00002
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix
- ClinicalTrials.gov ID
- NCT03762811
- Acronym / sponsor ID
- CPR-00002
- Conditions
- Bone; Degeneration
- Keywords
- Demineralized Bone Matrix, Bone Graft, Fusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NanoFUSE Biologics, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2019 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 4 Dec 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 purpose of this study is to determine fusion rates and compare clinical outcomes of the NanoFUSE® Bioactive Matrix during post-market clinical use.
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 or osseous defects created from traumatic injury to bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. This product provides a bone graft substitute that remodels into the recipient's skeletal system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NanoFUSE® PMCF | Other | Device: NanoFUSE® Bioactive MatrixNanoFUSE® Bioactive Matrix will be implanted according to labeling and the intended surgical treatment plan of the surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Skeletally mature
- Medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix consistent with product labeling
- Psychosocially, mentally, and physically able to fully comply with the protocol, including the post-operative regimen, requires follow-up visits, filling out required forms, and the ability to understand and give written informed consent
- Retrospective data collection must be allowed by the IRB and all information deidentified
Key exclusion criteria (8 listed)
- Previous fusion surgery of the proposed site
- Use of chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day)
- Pregnant or female intending to become pregnant during this study period
- Obesity (BMI >40kg/m2)
- Systemic infection or infection at the surgical site
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 MatrixNanoFUSE® is placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. | Device | NanoFUSE® PMCF |
Primary outcome
Radiographic Success that indicates patient achieving fused or probably fused status.
Time frame: 12 months
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 4 Dec 2018.
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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 in people with Bone; Degeneration, 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 4 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: status not confirmed, as of the sponsor's last update on 4 Dec 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 that indicates patient achieving fused or probably fused status. (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 4 Dec 2018.