A Clinical Study of the Dynesys(R) Spinal System

Exclusion Criteria

• •Primary diagnosis of discogenic back pain at affected levels as evidenced by a larger back than leg pain component. In the event of multi-level pathology a discogram should be considered;
• •Patients with leg pain due to etiologies other than those listed above, such as trauma, peripheral vascular disease and neuropathy should be excluded;
• •Degenerative scoliosis greater than 10 degrees at the affected motion segment;
• •Supplemental interbody column support (e.g., bone graft, spacers or fusion cages) is planned at the affected level(s);
• •Greater than Grade I spondylolisthesis or retrolisthesis at the affected level(s);
• •Radiculopathic signs from more than two contiguous or two noncontiguous vertebral body segment(s);
• •Previous lumbar fusion attempt(s), previous total facetectomy or trauma at the affected level(s);
• •Gross obesity defined as exceeding ideal weight by greater than 40% (measurement details are given in Appendix A);
• •Active local or systemic infection;
• •Advanced osteoporosis as evidenced by plain film radiographs or history of fractures and confirmed by DEXA scan to confirm adequate bone density;
• •Receiving immunosuppressive or long-term steroid therapy;
• •Active hepatitis (viral or serum) or HIV positive, renal failure, systemic lupus erythematosus, or any other significant medical conditions which would substantially increase the risk of surgery;
• •Documented history of titanium alloy, PET or PCU allergy, or intolerance;
• •Active malignancy or other significant medical comorbidities;
• •Current chemical dependency or significant emotional and/or psychosocial disturbance that may impact treatment outcome or study participation as evidenced by three or more positive Waddell Signs;
• •Pregnancy;
• •Incarceration;
• •Severe muscular, neural or vascular diseases that endanger the spinal column;
• •Missing bone structures, due to severely deformed anatomy or congenital anomalies, which make good anchorage of the implant impossible;
• •All concomitant diseases that can jeopardize the functioning and success of the patient;
• •Vertebral fractures;
• •Treatment of the thoracic and cervical spine;
• •Severely deformed anatomy due to congenital anomalies;
• •Paralysis