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Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762811
Recruitment Status : Unknown
Verified November 2018 by NanoFUSE Biologics, LLC.
Recruitment status was:  Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
NanoFUSE Biologics, LLC

Study Description
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Brief Summary:
This purpose of this study is to determine fusion rates and compare clinical outcomes of the NanoFUSE® Bioactive Matrix during post-market clinical use.

Condition or disease Intervention/treatment Phase
Bone; Degeneration Device: NanoFUSE® Bioactive Matrix Phase 4

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 or osseous defects created from traumatic injury to bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. This product provides a bone graft substitute that remodels into the recipient's skeletal system.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021
Arms and Interventions
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Arm Intervention/treatment
NanoFUSE® PMCF
NanoFUSE® Bioactive Matrix will be implanted according to labeling and the intended surgical treatment plan of the surgeon.
 Device: NanoFUSE® Bioactive Matrix
NanoFUSE® is placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.


Outcome Measures
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Primary Outcome Measures :
  1. Radiographic Success that indicates patient achieving fused or probably fused status. [ Time Frame: 12 months ]
    at 12 months


Secondary Outcome Measures :
  1. Overall patient success [ Time Frame: 12 months postoperatively ]
    Overall patient success will be based on all clinical and radiographic evaluation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Skeletally mature
  • Medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix consistent with product labeling
  • Psychosocially, mentally, and physically able to fully comply with the protocol, including the post-operative regimen, requires follow-up visits, filling out required forms, and the ability to understand and give written informed consent
  • Retrospective data collection must be allowed by the IRB and all information deidentified

Exclusion Criteria:

  • Previous fusion surgery of the proposed site
  • Use of chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day)
  • Pregnant or female intending to become pregnant during this study period
  • Obesity (BMI >40kg/m2)
  • Systemic infection or infection at the surgical site
  • Current or past substance abuse
  • Poor general healthy or any concurrent disease process that would place the patient in excessive risk to surgery (e.g. significant circulatory or pulmonary problems, cardiac disease
  • Medical condition that would interfere with post-operative assessments and care
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762811


Contacts
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Contact: Holly Cole 978-358-7307 ext 1004 hollycole@rqmis.com
Contact: Ashley Lyons 978-358-7307 ext 1005 ashleylyons@rqmis.com

Sponsors and Collaborators
NanoFUSE Biologics, LLC
More Information
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Responsible Party: NanoFUSE Biologics, LLC
ClinicalTrials.gov Identifier: NCT03762811    
Other Study ID Numbers: CPR-00002
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018

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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
Keywords provided by NanoFUSE Biologics, LLC:
Demineralized Bone Matrix
Bone Graft
Fusion