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