Efficacy and Safety of Lumbar Dynamic Stabilization Device Coflex for Lumbar Spinal Stenosis: A Systematic Review and Meta-analysis.

Background: This systematic review and meta-analysis were performed to investigate evidence for the comparison of lumbar dynamic stabilization device Coflex (Surgalign, Deerfield, IL) with posterior lumbar fusion for lumbar spinal stenosis).

Methods: Relational databases were searched to October 2022. The main outcome measures included operation time, Japanese Orthopedic Association score (JOA), visual analog scale (VAS), Oswestry disability index (ODI), total complications, and adjacent segment degeneration (ASD). Statistical analysis was performed with Review Manager 5.3 (Cochrane Collaboration).

Results: A total of 26 studies were included. The main results of this meta-analysis showed lumbar dynamic stabilization device Coflex had shorter operation time (mean difference [MD] -50.77 min, 95% CI -57.24 to -44.30, P < 0.00001), less intraoperative blood loss (MD -122.21 mL, 95% CI -129.68 to -94.74, P < 0.00001), and shorter hospital stays (MD -3.21 days, 95% CI -4.04 to -2.37, P < 0.00001). What's more, the JOA score and ODI score were higher in the Coflex group during early follow-up. Yet, there was no significant difference between the 2 groups with the extension of follow-up time. Moreover, the Coflex group had a lower VAS score than fusion treatment (P < 0.00001). Finally, the Coflex group had lower total complications rate (P = 0.03), lower ASD rate (P = 0.001), and higher range of motion (P < 0.00001), but there was no significant difference in reoperation rate and internal fixation problems rate.

Conclusions: Current evidence suggests that lumbar dynamic stabilization device Coflex is superior to posterior lumbar fusion in early follow-up. However, considering that the dynamic stabilization device group also has its limitations, these findings need to be further verified by multicenter, double-blind, and large-sample randomized controlled trials.