Charité Artificial Disc: Single-Level Lumbar Disc Disease
Charité Artificial Disc - Clinical Results Tell the Story: Part 2
In order to receive FDA approval, the Charité Artificial Disc had to undergo rigorous testing and clinical trials. A clinical trial is a type of research study that uses human volunteers to see if certain medications or treatments are safe and effective. Two such studies looking at the Charité Artificial Disc are discussed below.
The first study was based on a series of 40 patients each receiving the Charité Artificial Disc for single-level lumbar disc disease. Each patient's pain was assessed before the device was implanted. Patients were also seen by a spine surgeon 3 months, 6 months, 12 months, and 24 months after the surgery. Radiographs were taken at each of these visits. The surgeon also took measurements of exactly where the artificial disc was implanted so as to identify the ideal placement of the device and to see how the surgeons experience changed as more surgeries were performed.
The study results were promising. Overall, patients reported a significant decrease in pain after the surgery. In addition, improvements were made in the placement of the device. Surgeons were able to determine that the ideal place to implant the artificial disc was in the exact center of the disc space at the midpoint of the pedicles.
As is common in these types of studies, there were some patients who did not have a successful outcome. Several patients needed to have their artificial discs removed because the devices had became displaced. These patients then underwent anterior spinal fusion surgery with posterior instrumentation. Fortunately, there were no complications associated with removing the artificial disc.
The conclusions made by the spine surgeons were that despite a few complications, the Charité Artificial Disc is a highly successful treatment option for patients with single-level lumbar disc disease. They were also pleased to be able to identify the ideal placement site and noted that surgeon experience made a difference in a patient's outcome.