Status:
UNKNOWN
Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix
Lead Sponsor:
NanoFUSE Biologics, LLC
Conditions:
Bone; Degeneration
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
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 defec...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03762811
Start Date
February 1 2019
End Date
March 1 2021
Last Update
December 4 2018
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