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Decompression and Coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis: two-year results from the prospective, randomized, multicenter, Food and Drug

Abstract：

STUDY DESIGN:Prospective, randomized, multicenter, Food and Drug Administration Investigational Device Exemption trial. OBJECTIVE:To evaluate the safety and efficacy of Coflex interlaminar stabilization compared with posterior spinal fusion in the treatment of 1- and 2-level spinal stenosis and degenerative spondylolisthesis. SUMMARY OF BACKGROUND DATA:Long-term untoward sequelae of lumbar fusion for stenosis and degenerative spondylolisthesis have led to the search for motion-preserving, less-invasive alternatives. METHODS:Three hundred twenty-two patients (215 Coflex and 107 fusions) from 21 sites in the United States were enrolled between 2006 and 2010. Subjects were randomized to receive laminectomy and Coflex interlaminar stabilization or laminectomy and posterolateral spinal fusion with spinal instrumentation in a 2:1 ratio. Overall device success required a 15-point reduction in Oswestry Disability Index, no reoperations, no major device-related complications, and no postoperative epidural injections. RESULTS:Patient follow-up at minimum 2 years was 95.3% and 97.2% in the Coflex and fusion control groups, respectively. Patients taking Coflex experienced significantly shorter operative times (P < 0.0001), blood loss (P < 0.0001), and length of stay (P < 0.0001). There was a trend toward greater improvement in mean Oswestry Disability Index scores in the Coflex cohort (P = 0.075). Both groups demonstrated significant improvement from baseline in all visual analogue scale back and leg parameters. Patients taking Coflex experienced greater improvement in Short-Form 12 physical health outcomes (P = 0.050) and equivalent mental health outcomes. Coflex subjects experienced significant improvement in all Zurich Claudication Questionnaire outcomes measures compared with fusion (symptom severity [P = 0.023]; physical function [P = 0.008]; satisfaction [P = 0.006]). Based on the Food and Drug Administration composite for overall success, 66.2% of Coflex and 57.7% of fusions succeeded (P = 0.999), thus demonstrating noninferiority. The overall adverse event rate was similar between the groups, but Coflex had a higher reoperation rate (10.7% vs. 7.5%, P = 0.426). At 2 years, fusions exhibited increased angulation (P = 0.002) and a trend toward increased translation (P = 0.083) at the superior adjacent level, whereas Coflex maintained normal operative and adjacent level motion. CONCLUSION:Coflex interlaminar stabilization is a safe and efficacious alternative, with certain advantages compared with lumbar spinal fusion in the treatment of spinal stenosis and low-grade spondylolisthesis. LEVEL OF EVIDENCE:1.

journal_name

Spine (Phila Pa 1976)

journal_title

Spine

authors

Davis RJ,Errico TJ,Bae H,Auerbach JD

doi

10.1097/BRS.0b013e31829a6d0a

subject

Has Abstract

pub_date

2013-08-15 00:00:00

pages

1529-39

issue

eissn

0362-2436

issn

1528-1159

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Decompression and Coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis: two-year results from the prospective, randomized, multicenter, Food and Drug