Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft

Inclusion Criteria: Patient is indicated for primary lumbar fusion of 1 or 2 segments, L2 to S1 Patient is willing to be blindly randomized to treatment or control and remain blinded for 2 years of follow-up Patient is at least twenty-one (21) years of age Patient is expected to survive at least 2 years beyond surgery Patient is willing to participate by complying with pre- and postoperative visit requirements, including: completion of questionnaires, functional performance tests, and radiographs/CT scan Patient is willing and able to review and sign a study Informed Consent form Exclusion Criteria: Patient has a mental or physical condition that would invalidate evaluation results Patient is pregnant Patient is a prisoner Patient has a systemic infection or infection at the proposed surgical site Patient has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated Patient has a disease of bone metabolism Patient is undergoing chemotherapy or radiation treatment Patient is currently involved in a study of another product for a similar purpose Patient requires post-op management with nonsteroidal anti-inflammatory drugs (NSAIDs)