Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix

NanoFuse Biologics

Status and phase: Unknown; Phase 4

Conditions: Bone; Degeneration

Treatments: Device: NanoFUSE® Bioactive Matrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT03762811

CPR-00002

Details and patient eligibility

About

This purpose of this study is to determine fusion rates and compare clinical outcomes of the NanoFUSE® Bioactive Matrix during post-market clinical use.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

NanoFUSE® PMCF

Other group

Description:

NanoFUSE® Bioactive Matrix will be implanted according to labeling and the intended surgical treatment plan of the surgeon.

Treatment:

Device: NanoFUSE® Bioactive Matrix