A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System

Exclusion Criteria

• •Prior fusion surgery or another spinal device implanted in the thoracic, lumbar or sacral spine
• •Requires treatment of more than two vertebral levels
• •Lytic spondylolisthesis at the index level(s)
• •Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
• •Sustained pathologic fractures of the spine or hip, including prior fracture or trauma to vertebral structures at any thoracic, lumbar, or sacral level
• •Morbid obesity defined as a body mass index \> 40, or a weight more than 100 lbs over ideal body weight
• •Pregnant or interested in becoming pregnant within the next 2 years
• •Active systemic or local infection
• •Known allergy to device materials titanium, polycarbonate (PCU), polyethylene terepthalate (PET), or hydroxyapatite (HA).
• •Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids, excluding routine NSAIDs)
• •Systemic disease including AIDS, HIV, Hepatitis C
• •Has an active malignancy defined as a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years
• •Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, amyotrophic lateral sclerosis, etc.
• •Participation in an investigational device or drug clinical trials within 30 days of surgery
• •Acute mental illness or substance abuse
• •Prisoners