Davis et al. reported results of a prospective randomized multicenter trial (322 patients were enrolled from 21 sites) comparing decompression and Coflex interlaminar stabilization (Coflex) vs. traditional open decompression and instrumented posterior spinal fusion (PSF) for spinal stenosis and grade I degenerative spondylolisthesis (sponsored by the device manufacturer Paradigm Spine, LLC). The study reported use of Coflex interlaminar device is safe, with significantly shorter operative time, blood loss and length of stay compared to PSF. Coflex cohort has comparable patient outcome compared to traditional fusion cohort while maintaining adjacent level motion. This suggests a viable alternative for patients with moderate spinal stenosis and neurogenic claudication. Since one of the exclusion criteria is “severe facet hypertrophy that requires extensive bone removal” (best treated with lumbar decompression and fusion), then is either Coflex or lumbar fusion even needed for patients with only moderate stenosis without severe facet hypertrophy? It is interesting that within the two-year study period, 6% of the Coflex cohort required conversion to traditional lumbar fusion and another 3% need a revision decompression.
Source
Spine