ESCADA Trial Overview

In the ESCADA trial, the coflex device was compared to decompression alone. The objective of this study was to see if the coflex device was safe and if it was a better treatment option compared to decompression alone for patients with moderate to severe lumbar spinal stenosis with no instability (≤ Grade 1 spondylolisthesis).

Study Design:

  • 230 patients studied (115 coflex, 115 decompression alone)
  • 7 investigational locations
  • Follow up visits at 3, 12, and 24 months

Conclusion

The coflex device proved to be statistically superior compared to decompression alone for Composite Clinical Success* (CCS), increases walking distance, decreases compensatory pain management, and maintains foraminal height; thereby extending the durability and sustainability of a decompression procedure out to two years.

Walking Distance Median Improvement
Foraminal Height Change Over Time
Posterior Disc Height Maintenance
Overall Epidural Steroid Injections
Overall Epidural Steroid Injections
Composite Clinical Success

*CCS: Criteria where overall trial success was based on a composite endpoint; a combined outcome measure in which all four components must be met: 1) disability score improvement of at least 15 points; 2) no reoperations or subsequent lumbar injections; 3) neurological maintenance or improvement without worsening; and 4) no device- or procedure-related severe adverse events.