Ensayos clínicos

Inclusion Criteria:

• Skeletally mature adults between 22 and 75 years old.
• Subject has completed at least 6 months non-operative or conservative therapy.
• Subject has signed and dated the informed consent prior to any study related procedures.
• Subject must have back pain with radicular symptoms as evidenced by leg pain, which has been confirmed by history and physical exam.
• Subject must have Degenerative Disc Disease confirmed by history and radiographic findings, stenosis, spondylolisthesis or scoliosis necessitating a Subject’s surgical procedure must involve disc(s) between L2 and S1.
• Planned lumbar fusion at a one level only.
• Subject is willing and able to participate in the study follow-up according to the protocol.
• Subject is willing and able to comply with postoperative management program.

Exclusion Criteria:

• Subject has a systemic infection such as AIDS, HIV, or active hepatitis.
• Subject has an autoimmune disease.
• Subject has significant metabolic disease that, in the surgeon’s opinion, might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia.
• Subject has history of malignancy.
• Surgery for primary tumor, trauma or infection.
• Subject requires 2 or more levels of fusion.
• Subject has had previous spinal instrumentation or a previous interbody fusion procedure at the involved level.
• Subject has spondylolisthesis ≥ grade 2.
• If you are pregnant, plan to become pregnant or are breast feeding you cannot be in this study.