Status:
UNKNOWN
NanoFUSE® PL Gutter PMCF
Lead Sponsor:
NanoFUSE Biologics, LLC
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 defec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03751943
Start Date
January 1 2019
End Date
March 1 2021
Last Update
November 23 2018
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