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NanoFUSE® PL Gutter PMCF

Primary Purpose

Degenerative Disc Disease

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)
Sponsored by
NanoFUSE Biologics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Demineralized Bone Matrix, Primary Lumbar Fusion, Autograft Lumbar Fusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    NanoFuse® PL Gutter

    Arm Description

    NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) within one posterolateral gutter (unilateral)

    Outcomes

    Primary Outcome Measures

    Radiographic Success
    All patients achieving fused or probably fused status will be judged as successes at 12 months.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    November 20, 2018
    Last Updated
    November 21, 2018
    Sponsor
    NanoFUSE Biologics, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03751943
    Brief Title
    NanoFUSE® PL Gutter PMCF
    Official Title
    Clinical Investigation of NanoFUSE® Bioactive Matrix and Autogenous Bone in Posterolateral Spinal Fusion (Nonloadbearing)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    March 2021 (Anticipated)
    Study Completion Date
    March 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NanoFUSE Biologics, LLC

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Degenerative Disc Disease
    Keywords
    Demineralized Bone Matrix, Primary Lumbar Fusion, Autograft Lumbar Fusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NanoFuse® PL Gutter
    Arm Type
    Other
    Arm Description
    NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) within one posterolateral gutter (unilateral)
    Intervention Type
    Device
    Intervention Name(s)
    NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)
    Intervention Description
    NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter
    Primary Outcome Measure Information:
    Title
    Radiographic Success
    Description
    All patients achieving fused or probably fused status will be judged as successes at 12 months.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Overall patient success
    Description
    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
    Time Frame
    12 months postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Holly Cole
    Phone
    978-358-7307
    Ext
    1004
    Email
    hollycole@rqmis.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    John McGuire
    Phone
    978-358-7307
    Ext
    1003
    Email
    johnmcguire@rqmis.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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