Activ-L Artificial Disc in the Treatment of Lumbar Degenerative Disc Disease (DDD)

The purpose of this study is to learn whether an investigational device called the Activ-L Artificial Disc is safe and effective in the treatment of degenerative disc disease of the lower (lumbar) spine. An investigational device is not approved for use or marketing by the US Food and Drug Administration (FDA) except in studies such as this one. In this study the Activ-L Artificial Disc (investigational group treatment) will be compared to the Synthes Spine ProDisc-L Total Disc Replacement and the  DePuy Charité Artificial Disc that have been approved by the United States Food and Drug Administration (FDA) (control group treatments). One of the goals of this study is to see if the Activ-L Artificial Disc performs as well as the ProDisc-L Total Disc Replacement and the Charité Artificial Disc.

The DePuy Charité Artificial Disc is the control group disc being used at this study site. The ProDisc-L device will be available at other study sites, but not at this one.  For every 3 subjects enrolled in the study at Rush, two will receive the Activ-L Artificial Disc and one will receive the Charité Artificial Disc.

Approximately 414 subjects will take part in this study in the United States.

You may be eligible to participate in this study if you:

• Are 18 to 60 years of age and skeletally mature
• Have symptomatic DDD with objective evidence of lumbar DDD based on MRI
• Have single level symptomatic disease at L4/L5 or L5/S1
• Have had a minimum of 6 months of unsuccessful conservative treatment, including but not limited to physical therapy and/or medication

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.