CClinicalTrials.gg
Sign In
Status unknownNCT03762811Updated Dec 4, 2018

Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix

A Phase 4 interventional study of NanoFUSE® Bioactive Matrix in Bone; Degeneration, sponsored by NanoFUSE Biologics, LLC. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-04.

Sponsored by NanoFUSE Biologics, LLC · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bone; Degeneration

Keywords

  • Demineralized Bone Matrix
  • Bone Graft
  • Fusion
03

In context

Lead sponsor

NanoFUSE Biologics, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    NanoFUSE® PMCF

    NanoFUSE® Bioactive Matrix will be implanted according to labeling and the intended surgical treatment plan of the surgeon.

    Device: NanoFUSE® Bioactive Matrix

Interventions

  • DeviceNanoFUSE® 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.

06

What researchers measure

Primary outcomes

  1. Radiographic Success that indicates patient achieving fused or probably fused status.

    at 12 months

    Time frame: 12 months

Secondary outcomes

  1. Overall patient success

    Overall patient success will be based on all clinical and radiographic evaluation

    Time frame: 12 months postoperatively

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03762811
Lead sponsor
NanoFUSE Biologics, LLC
Responsible party
Sponsor
First posted
Dec 4, 2018
Start date
Feb 2019 (estimated)
Primary completion
Mar 2021 (estimated)
Completion
Mar 2021 (estimated)
Last update
Dec 4, 2018

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

NanoFUSE Biologics, LLC

Start the discussion