The spine journal : official journal of the North American Spine Society
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Prospective randomized study of the Charite artificial disc: data from two investigational centers.
For decades there has been a desire to restore motion of a painful degenerated spinal segment. Artificial discs have been used in Europe for almost 20 years. In the few reports available in the literature, the results have been promising. However, there have been no prospective randomized studies comparing artificial discs with spinal fusion. ⋯ In this prospective randomized study, both surgical groups improved significantly. Complications of total disc replacement were similar to those encountered with anterior lumbar interbody fusion. Total disc replacement appears to be a viable alternative to fusion for the treatment of single-level symptomatic disc degeneration unresponsive to nonoperative management.
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Multicenter Study Clinical Trial
The Lumbar I/F Cage for posterior lumbar interbody fusion with the variable screw placement system: 10-year results of a Food and Drug Administration clinical trial.
The Lumbar I/F Cage is a carbon fiber reinforced polymer (CFRP) device designed to separate the mechanical and device functions of interbody fusion. A Investigational Device Exemption (IDE) clinical study of the CFRP cage was conducted during an enrollment period from 1991 to 1993. Based on the 2-year results of this study, the cage was approved by the US Food and Drug Administration (FDA) in February 1999. Since then, the Lumbar I/F Cage device has become widely used in the United States. ⋯ The high rate of clinical success, fusion success, and patient satisfaction at 24 months was maintained at 10-year follow-up. Adjacent segment degeneration was common but was usually not clinically significant.