Charite Clinical Trial Data Released at AANS 25% Owestry Pain Improvement, Better Motion than a BAK Cage
BY EDITOR, MARCH 29, 2004
Phase III clinical trial data for JNJ's Charite artificial lumbar disc was presented last week at the AANS/CNS conference in San Diego. This equivalency study compared patients having the Charite with patients with the BAK Intervertebral body cage (see table below). The primary endpoint was back pain as measured using the Owestry Pain score (scale of 1-10, with 10 being most pain). Secondary endpoints included range of motion and increase in disc height. The indication was for treatment of degenerative disc disease (DDD).
The following tables summarize the data from the trial:
One of the principal reasons surgeons are interested in motion preservation technologies like the Charite is the hope that they will reduce adjacent level disease. Fusing vertebrae sets up a change in the biomechanics of the spine as load bearing shifts to levels adjacent to the fused section. About 30-40% of all fused patients return for treatment of adjacent level DDD in 10 years. In Europe, where such motion preserving technologies as the Charite, the Pro Disc, the Maverick or the PDN have been used in thousands of patients over several years, the incidence of adjacent level disease appears to be less.
