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.
Study Type
OBSERVATIONAL
Enrollment
110
Orange County Neurological Associates
Laguna Hills, California, United States
Orthpedic Specialists of Northwest Indiana
Munster, Indiana, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Baystate Medical Center
Springfield, Massachusetts, United States
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.
Time frame: 12 months or more after device implantation; mean follow up 20.7 months
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.
Time frame: 12 months (Last available visit) post surgery
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New England Orthopedic Surgeons
Springfield, Massachusetts, United States
St Francis Hospital
Greenville, South Carolina, United States
Franciscan Neurosurgery Associates
Tacoma, Washington, United States