Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial

Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion

This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.

Inclusion Criteria:

• Male and female patients age 18-75 years
• Chronic low back pain unresponsive to at least six months of conservative care
• MRI and standing x-ray evidence of Pfirrmann Grade III or greater disc degeneration and/or degenerative or isthmic spondylolisthesis of Grade I or II

Exclusion Criteria:

• Osteoporosis
• Patients with prior failed fusion at the same level
• Degenerative scoliosis
• Degenerative spondylolisthesis greater than Grade II
• Pregnancy
• Psychiatric or mental disease
• Alcoholism (drinking more than 5 units per day)
• Active infection or prior infection at the surgical site
• Active cancer
• Insufficient language skills to complete questionnaires
• Participation in another study
• More than two symptomatic levels that need fusion