Artificial Intervertebral Disc Replacement for Lumbar Degenerative Disc Disease
October 14, 2009 | Emerging Technology Reports
The evidence base consists of two randomized controlled trials that assessed a total of 596 patients.
Limitations of the evidence base include lack of blinding, inadequate data reporting to estimate adverse event rates, and lack of long-term follow-up in controlled trials for comparison to spinal fusion, the standard surgical treatment.
The results from both randomized controlled trials are consistent for several outcomes: pain improvement, health-related disability improvement, length of hospital stay, and patient satisfaction.
This Emerging Technology Evidence Report provides an analysis of full published studies in the clinical literature through August 15, 2007. We updated the literature search through a Hotline Response by searching PubMed and The Cochrane Library for relevant documents published from August 16, 2007 through Jan 26, 2009. Those searches identified one systematic review (Harrop et al. 2008), five-year results of a previously published randomized controlled trial (RCT) (Guyer et al. 2008); one new RCT (Sasso et al. 2008), seven comparison studies, and nine case series. The findings of the publications identified for the Hotline Response are generally consistent with those of our previous report: Guyer et al. reported five-year results of an RCT that are consistent with the two-year results of noninferiority of Charité artificial discs compared to fusion. Sasso et al. reported that the FlexiCore disc compares favorably to fusion to treat lumbar degenerative disc disease that is unresponsive to conservative treatment. Some of the other publications were post hoc analyses or intermediate outcome analyses of RCTs that were previously discussed in the Emerging Technology Evidence Report.
Proprietary Names: Activ-L Artificial Disc; CAdisc; Charité Artificial Disc System; CL Disc; Dynardi Dynamic Artificial Disc System; eDisc; FlexiCore Lumbar Intervertebral Disc Replacement;...