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

Study Overview
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Brief Summary
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The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative disc disease between C2 and T1 in the short term, with a focus on fusion rates.

Official Title
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An Open-Label Clinical Study of the Safety and Efficacy of the ROI-C Anterior Cervical Interbody Fusion Device Using the VerteBRIDGE Plating System

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: ROIC interbody cage with VerteBRIDGE plating


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level between C2 and T1. The subject can have the ROI-C device at only one level. Autograft must have been used with the ROI-C device. Subject should have had a minimum of 6 (six) weeks of non-operative treatment prior to surgery. Subject must be at least 21 years of age at the time of surgery Exclusion Criteria: No BMP was used in the interbody cage Subject was a prisoner at the time of surgery 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>ROIC interbody cage with VerteBRIDGE plating | Device: ROIC 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 |
| --- | --- | --- |
| Percentage of Participants With Fusion | Rate of fusion using A/P, lateral, and flexion/extension radiographs at each time point; defined by the presence of bridging bone with less than 2° segmental motion in flexion/extension and less than 3mm of A/P translation. | 12 months or more after device implantation; mean follow up 20.7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain | NDI is a standard instrument for measuring self-rated disability due to neck pain. It is scored from 0-50, with results multiplied by 2 to arrive at a percentage. Lowest scores represent no disability, high scores represent worse disability. A VAS is a measurement instrument for pain that measures the degree across a continuum or straight line. The endpoints define extreme limits, from 0-10, with 0 representing no pain and 10 severe pain. | 12 months (Last available visit) post surgery | 

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