Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: ROIA Interbody Cage with VerteBRIDGE plating


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Operated Subjects<br>ROIA Interbody Cage with VerteBRIDGE plating | Device: ROIA Interbody Cage with VerteBRIDGE plating<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Fusion | Fusion was assessed utilizing both AP and flexion/extension radiographs. Fusion was noted when all three of the criteria were present: 1) presence of bridging bone as identified by radiography, 2)Less than 5 degrees of segmental motion on flexion/extension radiographs, and 3) Less than 3 mm of A/P translation on flexion/extension radiographs | 12 months after device implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Oswestry Disability Index | The Oswestry Disability Index (ODI) is and index to quantify disability for low back pain. There are 50 possible points which are multiplied by 2 to arrive at a percentage score. Zero is equated with no disability and 100 is the maximum disability possible | 12 months after device implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DDD, lumbar spine, fusion rate, degenerative disc disease