NanoFUSE® PL Gutter PMCF

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

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.

Study Overview

• Status: Unknown
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NanoFuse® PL Gutter; NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) within one posterolateral gutter (unilateral)	Device: NanoFUSE® Bioactive Matrix (75%) w/autograft (25%); NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Success	All patients achieving fused or probably fused status will be judged as successes at 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall patient success	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	12 months postoperatively

Collaborators and Investigators

• Sponsor: NanoFUSE Biologics, LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Demineralized Bone Matrix; Primary Lumbar Fusion; Autograft Lumbar Fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: CPR-00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes