NanoFUSE® PL Gutter PMCF
Clinical Investigation of NanoFUSE® Bioactive Matrix and Autogenous Bone in Posterolateral Spinal Fusion (Nonloadbearing)
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2019
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedNovember 23, 2018
November 1, 2018
2.2 years
November 20, 2018
November 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiographic Success
All patients achieving fused or probably fused status will be judged as successes at 12 months.
12 months
Secondary Outcomes (1)
Overall patient success
12 months postoperatively
Study Arms (1)
NanoFuse® PL Gutter
OTHERNanoFUSE® Bioactive Matrix (75%) w/autograft (25%) within one posterolateral gutter (unilateral)
Interventions
NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2018
First Posted
November 23, 2018
Study Start
January 1, 2019
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
November 23, 2018
Record last verified: 2018-11