Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix
Phase 4
- Conditions
- Bone; Degeneration
- Interventions
- Device: NanoFUSE® Bioactive Matrix
- Registration Number
- NCT03762811
- Lead Sponsor
- NanoFUSE Biologics, LLC
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NanoFUSE® PMCF NanoFUSE® Bioactive Matrix NanoFUSE® Bioactive Matrix will be implanted according to labeling and the intended surgical treatment plan of the surgeon.
- Primary Outcome Measures
Name Time Method Radiographic Success that indicates patient achieving fused or probably fused status. 12 months at 12 months
- Secondary Outcome Measures
Name Time Method Overall patient success 12 months postoperatively Overall patient success will be based on all clinical and radiographic evaluation