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

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

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.

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.