NCT03751943

NanoFUSE® PL Gutter PMCF

Clinical Investigation of NanoFUSE® Bioactive Matrix and Autogenous Bone in Posterolateral Spinal Fusion (Nonloadbearing)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: NanoFUSE Biologics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal fusion.

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 created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine. This product provides a bone graft substitute that remodels into the recipient's skeletal system. Radiographic success will be the primary judgement of success. All patient's achieving fused or probably fused status will be judged as a success.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)	NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2018-11-23
• Last updated: 2018-11-23

Regulatory

• FDA-regulated device study