Intralaminar device effective for stabilizing low grade lumbar spondylolisthesis slips
AMSTERDAM — In an investigational device exemption trial of an intralaminar lumbar stabilization implant, U.S. investigators found it treated low-grade spondylolisthesis as well as laminectomy and posterior fusion at 24 months.
At Spine Week 2012, here, Joshua D. Auerbach, MD, presented results from a subset of patients included in the 335-patient, 20-center investigational device exemption trial for the Coflex intralaminar system (Paradigm Spine LLC; New York).
“Coflex intralaminar stabilization is a viable alternative to fusion in degenerative spondylolisthesis,” he said.
The cohort Auerbach reported on consisted of 64 patients with the Coflex implant and 34 control patients who underwent pedicle screw fusion with local autograft bone. All patients underwent surgical decompression and were then randomized 2:1 to the Coflex and fusion groups.
None of the fusions involved bone morphogenetic protein or cages.
“Perioperative outcomes revealed that the hospital length of stay, estimated blood loss and operative times all were significantly reduced with the Coflex group compared with the control group and these differences were more pronounced in the 2-level procedures,” Auerbach said of this group of patients, who had grade 1 degenerative spondylolisthesis and severe back pain and stenosis at the outset of the study.
The baseline and 24-month results were similar in the two groups for Oswestry Disability Index (ODI) scores and Visual Analog Scale back and leg scores, but Auerbach said “there were significant improvements in some of the early postoperative time points in the Coflex group” for the ODI.
“There were no differences with respect to SF-12 at baseline or at any postoperative time point, but there was a trend for its improvement in the mental [domain] at 24 months,” he said.
However, results showed Coflex was superior to fusion regarding perioperative outcomes and each of the Zung Claudication Questionnaire outcome measures, Auerbach said.
- Davis R, Auerbach J, Bae H, Errico T. Low-grade spondylolisthesis can be effectively treated by either Coflex interlaminar stabilization or laminectomy and posterior spinal fusion: Two-year clinical and radiographic results from the US IDE trial. Paper #12. Presented at SpineWeek 2012. May 28-June 1. Amsterdam.