Synthes, Inc. (Synthes), is planning to complete the the clinical trial entitled “A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP for Treatment of Moderate Degenerative Lumbar Spinal Stenosis” for the product In-Space by December 2011. The aim of the study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device (X STOP). The trial is for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels. This phase III trail is being conducted in various locations of US.
The randomized, open label, parallel assignment, safety/efficacy study is ongoing, but not recruiting participants. The trial is estimated to enroll 500 participants.
In-Space is a interspinous spacer device which uses the process of interspinous distraction. Using a percutaneous approach, requiring a 1.5 cm incision for the insertion of a series of tools that use blunt dilation rather than cutting to get past spine muscles and position the implant. To position the insertion sleeve that will guide the implant for placement between the vertebrae, the intra-spinous ligament is pierced but significantly, the supra-spinous ligament is not touched. This device enables treatment of lumbar stenosis.