NCT03762811

Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: NanoFUSE Biologics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone; Degeneration

Interventions

Type	Name	Description
DEVICE	NanoFUSE® Bioactive Matrix	NanoFUSE® is placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.

Timeline

• Start date: 2019-02-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2018-12-04
• Last updated: 2018-12-04

Regulatory

• FDA-regulated device study