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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03751943
Study type Interventional
Source NanoFUSE Biologics, LLC
Contact Holly Cole
Phone 978-358-7307
Email hollycole@rqmis.com
Status Not yet recruiting
Phase Phase 4
Start date January 2019
Completion date March 2021

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