Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating
This trial is active, not recruiting.
|Condition||degenerative disc disease|
|Treatment||roia interbody cage with vertebridge plating|
|Sponsor||LDR Spine USA|
|Start date||November 2013|
|End date||April 2016|
|Trial size||51 participants|
|Trial identifier||NCT02104141, ROIA100|
The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level degenerative disc disease between L2 and S1, with a focus on fusion rates and patient outcomes.
ROIA Interbody Cage with VerteBRIDGE plating
Time to Fusion
time frame: 12 months after device implantation
Percentage of subjects with an improvement in Oswestry Disability Index
time frame: 12 mo. or more after initial date of surgery
Male or female participants at least 21 years old.
Inclusion Criteria: - Subjects must have degenerative disc disease (DDD) of the lumbar spine between L2 and S1 - 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 had more than Grade 1 spondylolisthesis at the operated level - Subject is a prisoner. - Subject was pregnant at the time of surgery. - Subject had an active infection or sepsis at the time of surgery.
|Official title||An Open Label, Multicenter, Clinical Study of the Safety and Efficacy of the LDR Spine ROI-A Interbody Fusion System Using the VerteBRIDGE™ Plating System|
|Principal investigator||Christian M DuBois, MD|
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