NanoFUSE® PL Gutter PMCF
NCT03751943 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2018-11-23
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.
Conditions
- Degenerative Disc Disease
Interventions
- DEVICE
-
NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)
NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter
Sponsors & Collaborators
-
NanoFUSE Biologics, LLC
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-31
- Primary Completion
- 2021-03-31
- Completion
- 2021-03-31
- FDA Device
- Yes
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