Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)

Inclusion Criteria:

- Symptomatic lumbar degenerative disc disease in up to two contiguous levels between
L1 and S1

- Subjects with back and/or leg pain indicated for posterior stabilization with or
without decompression at any level and posterolateral fusion (PLF)

- Unresponsive to conservative treatment for at least 6 months

- Radiographic evidence of primary diagnosis

Exclusion Criteria:

- More than 2 levels requiring posterolateral fusion

- Spondylolisthesis greater than Grade I

- Prior failed fusion surgery at any lumbar level(s)

- Systemic or local infection in the disc or cervical spine, past or present

- Active systemic disease

- Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly
inhibit bone healing

- Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes
in addition to or in place of those products specified

- BMI greater than 40

- Use of post operative Spinal Cord Stimulator (SCS)

- Known or suspected history of alcohol and/or drug abuse

- Involved in pending litigation or worker's compensation related to the spine

- Pregnant or planning to become pregnant during the course of the study

- Insulin-dependent diabetes mellitus

- Life expectancy less than duration of study

- Any significant psychological disturbance that could impair consent process or
ability to complete self-assessment questionnaires

- Undergoing chemotherapy or radiation treatment, or chronic use of oral or injected
steroids or prolonged use of non-steroidal anti-inflammatory drugs.

- Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide
(DMSO)