A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)

Exclusion Criteria

• •The need for interbody cages, allograft, or any other assistance during surgery. Device is only to be used with autograft per FDA approved indications.
• •Any medical, mental or surgical condition precluding the potential benefit of spinal surgery or surgery in general.
• •Acute or chronic systemic, spinal or localized infections.
• •Active, severe systemic and metabolic diseases.
• •Obesity defined as Body Mass Index \> 35.
• •Subject is pregnant or interested in becoming pregnant in the next 36 months.
• •Dependency on pharmaceutical drugs, drug abuse, or alcoholism.
• •Lack of patient cooperation.
• •Foreign body sensitivity to the implant material.
• •Degenerative scoliosis greater than 25 degrees.
• •Grade 4 degenerative spondylolisthesis (\>75% slip).
• •Significant osteopenia A screening questionnaire for osteopenia, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required\*, exclusion will be defined as a DEXA bone density measured T score of ≤ -1.0 (The World Health Organization definition of osteopenia).
• •Soft tissue deficit not allowing wound closure.
• •Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device.
• •Inadequate pedicles or vertebral body geometry of the thoracic, lumbar and sacral vertebrae.
• •Bony lumbar spinal stenosis not related to the primary degenerative spondylolisthesis indication.
• •Pars defect.
• •Clinically compromised vertebral bodies at affected level due to current or past trauma.
• •Prisoner or ward of the state.
• •Currently in litigation regarding a spinal condition.
• •Known allergy to titanium, titanium alloys, CoCrMo, polyethylene or MR contrast agents.
• •Is currently involved in a study of another investigational product for similar purpose.