Results of FDA Clinical Trial Comparing Disc Replacement with Spinal Fusion
Sometimes chronic low back pain (LBP) doesn't respond to conservative care. Surgery may be needed for LBP caused by degenerative disc disease. Spinal fusion has been the standard procedure used. Fusion helps decrease the pain but patients are left with decreased motion as a result.
Artificial disc replacement (ADR) may be changing the treatment options for these patients. Clinical trials are underway comparing the results of fusion with disc replacement. In this FDA-regulated study, the results are reported for 286 patients from 17 different clinics around the United States. There were 38 surgeons involved.
Two-thirds of the patients received a ProDiscÂ®-L total disc replacement. One-third had a circumferential fusion. Circumferential fusion means the diseased spinal level was fused from the front, side, and back. Bone graft and screws were used as fusion materials. In both groups, only one lumbar level (between L3 and S1) was treated.
All patients were followed for two years. Results were measured using change in symptoms, function, disability, and satisfaction. Before and after X-rays were taken in both groups. Range of motion was measured for the patients with disc replacements.
The authors report both groups showed improvement in function and disability measures. The ADR group had better overall results. Possible complications after surgery are different for the two different treatment methods. With ADR, there can be sinking or slipping of the device out of place. With fusion, sometimes the fusion doesn't take, and the patient still has painful movement at the diseased level.
In this study, patients in the ADR group were much happier with the results of their surgery compared to the fusion group. The results of this study suggest Pro-DiscÂ®-L is safe and effective. With the right patients, the results are superior to spinal fusion. Maintaining normal range of motion is a clear benefit of this device.
Jack Zigler, MD, et al. Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDiscÂ®-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease. In Spine. May 15, 2007. Vol. 32. No. 11. Pp. 1155-1162.