Study to Investigate the Long Term Survivorship of Coflex

Study to Investigate the Long Term Survivorship of Coflex CT Study: Sub-Analysis of 24 Month Spinous Process Fractures Via Post-60 Month CT Scan

Examine the long-term survivorship via CT Scan of the coflex in patients who presented with spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.

This is a prospective, multi-center, single-arm, radiographic evaluation of all coflex IDE patients who presented with a spinous process fracture at 24 months as identified by independent radiographic review (using X-ray or CT). All patients were enrolled and followed through 60 months under the IDE and extended follow-up protocol.

The specific objective of this CT Study is to perform a sub-analysis of the patients with 24 month spinous process fracture(s) via a CT scan at post-60 months. A CT Scan will be performed and analyzed by an independent radiographic review lab for evidence of fracture or healing at the long term timepoint.

Inclusion Criteria:

• Participant in coflex IDE Study
• Willing and able to give informed consent
• Spinous process fracture identified by site and/or radiographic lab at 24 months

Exclusion Criteria:

• Subjects who died, were withdrawn or withdrew consent to participate in the study
• Subjects who are pregnant, or planning to become pregnant, during the course of this study
• Subjects who have cancer, whether active or in remission