NanoFUSE® PL Gutter PMCF

Phase 4

• Conditions: Degenerative Disc Disease
• Interventions: Device: NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)

• Registration Number: NCT03751943
• Lead Sponsor: NanoFUSE Biologics, LLC

Brief 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.

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-21
• Last Update Submitted: 2018-11-21
• Study First Posted: 2018-11-23
• Last Update Posted: 2018-11-23
• Study Start: 2019-01
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Grade I or II (less than 50% slip f the cephalic vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L5
• Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of nonsurgical treatment, or such patients with worsening neurological condition
• Patients who are medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix is consistent with product labeling
• Patients who have consented for surgical treatment
• Patients able to provide informed consent for the study and complete the questionnaires

Exclusion Criteria

• Lytic spondylolisthesis
• Non degenerative stenosis (example: tumor, trauma, epidural, lipomatosis)
• Segmental kyphosis at the level of the spondylolisthesis
• Rheumatoid arthritis
• Active infection
• On long term disability or workers compensation claim

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NanoFuse® PL Gutter	NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)	NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) within one posterolateral gutter (unilateral)

Primary Outcome Measures

Name	Time	Method
Radiographic Success	12 months	All patients achieving fused or probably fused status will be judged as successes 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 parameters and complications for the indication for use.; Success criteria includes the following: * Presence of radiographic fusion as evidenced by identification of new bone mass; * No hardware failure or screw blackout; * Decreased level of pain (VAS); * Maintained or improved level of function (ODI); * Maintained or improved neurological status