Charité Artificial Disc Study

Spine surgeons at CINN are conducting a clinical investigation using the Charité device for total disc replacement. The study is designed to test the safety and effectiveness of the Charité Artificial Disc in treating degenerative disc disease.

There are two ‘arms’ (segments) to this study. In the first arm, approximately 366 patients were enrolled at 15 sites across the country during the ‘randomized’ segment of the study. Enrollment into the first arm of the study is closed. The second arm of the study is currently being conducted and is expected to enroll 600 patients at 17 sites.

The first arm of the study compared the Charité Artificial Disc (investigational group) to the BAK Cage Interbody Fusion System (control group). Patients were randomized (much like a flip of a coin) to the device they received. Two out of every three patients were randomized to receive the Charité Disc. All of the patients involved in the first arm of the study are in the process of being followed by their surgeons post-operatively for 24 months. Enrollment to the first arm of the study is closed.

In May 2002, CINN surgeons began enrolling patients into the second arm of the study. This segment of the study does not involve randomization to a treatment group, therefore every patient approved for this arm of the study will receive the Charité device. As mentioned above, approximately 600 patients will be enrolled at up to 17 sites across the nation. Patients who meet all of the study criteria and are approved for the procedure by both the surgeon and the Sponsor of the research may be enrolled in the study.

The overall purpose of the surgery is to relieve back pain, which is most likely caused by a condition called “degenerative disc disease”. The condition may take many forms and doctors may use a different name. Regardless of the name, the disc does not work properly and causes pain with movement.

The Charité Artificial Disc is a prosthesis system consisting of material which has been proven to be extremely well tolerated by the body. Much like an artificial hip or knee system that relies on metal and plastic to replicate normal movement, the Charité is designed to mimic the function of a healthy disc.

Potential study candidates must meet the following criteria:

	Have single level degenerative disc disease at L4-5 or L5-S1
	Be between 18 and 60 years of age
	Have low back pain, rather than leg pain as the major complaint
	Pain must have persisted for at least six months

No history of thoracic or lumbar fusion For more information, please contact Michelle Catalano, Clinical Research Coordinator at CINN at the Neurologic & Orthopedic Institute of Chicago, 4501 North Winchester Avenue, 3rd Floor, Chicago, Illinois, 60640 or by phone at (773) 250-0500.