TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

A Prospective Clinical Investigation of the TRIUMPH Lumbar Disc: A Pilot Study

The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH® Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc Disease (DDD) at one level from L1 to S1.

Inclusion Criteria:

• Degenerative Disc Disease in one vertebral level between L1 and S1
• Able to understand and sign informed consent
• Had at least 6 months of conservative treatment
• Oswestry Disability Index Score of at least 30 (one a 100 point scale)
• Other inclusion criteria as specified in approved IDE protocol

Exclusion Criteria:

• Bilateral leg pain
• Back or leg pain of unknown etiology
• Prior fusion surgery or another spinal device implanted at any other lumbar level
• Osteoporosis or osteopenia
• Other exclusion criteria as specified in approved IDE protocol