Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating
NCT ID: NCT02104141
Last Updated: 2019-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
51 participants
OBSERVATIONAL
2013-11-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Operated Subjects
ROIA Interbody Cage with VerteBRIDGE plating
ROIA Interbody Cage with VerteBRIDGE plating
Interventions
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ROIA Interbody Cage with VerteBRIDGE plating
Eligibility Criteria
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Inclusion Criteria
* Subjects may have up to a Grade 1 spondylolisthesis at the involved level(s)
* Subject must have the ROI-A® device at one level or at two contiguous levels between L2 and S1 only
* Subject should have had a minimum of 6 months non-surgical treatment prior to receiving the ROI-A® device
* Subject may have had NO MORE THAN two previous non-fusion surgeries to the lumbar spine at the same levels as the ROI-A®
* Subject must be at least 21 years of age at the time of surgery
* Subject must be willing to signed an informed consent document and return for a 12 month visit
Exclusion Criteria
* Subject is a prisoner.
* Subject was pregnant at the time of surgery.
* Subject had an active infection or sepsis at the time of surgery.
21 Years
ALL
No
Sponsors
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LDR Spine USA
INDUSTRY
Responsible Party
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Other Identifiers
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ROIA100
Identifier Type: -
Identifier Source: org_study_id
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