Study of the Long-Term Outcomes of Posterior Spinal Fixation With the Karma Device

Exclusion Criteria

• •1. Patients with greater than two levels of degenerative disease or deformity for INTENDED operative levels.
• •2. Previous fusion or total disc replacement at the intended level/s
• •3. Known allergy to implant and instrument materials
• •4. Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
• •5. Degenerative spondylolisthesis of grade \>2
• •6. Isthmic spondylolisthesis
• •7. Back or leg pain of unknown etiology
• •8. Active systemic infection or infection at the location planned surgery
• •9. Active or suspected malignancy. If symptom free for 2 years, patients with prior malignancy may be included.
• •10. Morbid obesity defined as a body mass index \> 40
• •11. Patient being treated for other specific medical conditions that may affect bone density or the ability to obtain fusion (ie: steroids, etc)
• •12. Pregnant or have plans to become pregnant in the next year.
• •13. Currently a prisoner
• •14. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
• •15. Participation in a concurrent clinical study.