Artificial Discs and Back Surgery
The FDA approved the device based on a clinical study of safety and effectiveness conducted by DePuy at 16 medical centers. The objective of the study was to determine whether the Charité artificial disc was any less safe and effective than a commercially available spinal fusion cage using bone graft.
The firm studied the use of the artificial disc in 205 patients who had been diagnosed with DDD and who had failed to have their pain relieved after six months of non-surgical therapy, and compared them to 99 patients who received the control device. Additional safety information was obtained from another 71 patients when doctors in the study were being trained to use the Charité artificial disc.
The study showed that two years after surgery, patients treated with the artificial disc were not worse than patients treated with intervertebral body fusion. The rates of adverse (harmful) events from use of the artificial disc were similar to those from treatment with fusion. In addition, the study showed that there was no statistically significant relationship between motion at the level where the disc was implanted and the patient's relief from pain.