In January 2007, Applied Spine received permission to begin a randomized, controlled clinical study to compare the Stabilimax NZ® Dynamic Spine Stabilization System against traditional posterolateral fusion. To facilitate this multi-center study, the company turned to Syndicom, the premier developer of collaborative communities, and its widely embraced SpineConnect platform, which is currently used by over 900 spine surgeons around the world. Surgeons participating in the clinical trial use SpineConnect's TrialEdge, a unique Web-based service built on Syndicom's proven collaboration methodology, to improve their ability to identify, enroll, and retain patients. As a result, Applied Spine has seen faster patient enrollment, better trial quality, and lower costs. An added advantage has been the generation of teaching cases for educational purposes, marketing, and research, and development.
Applied Spine Technologies Inc., headquartered in New Haven, Connecticut, received FDA approval to begin an IDE trial on its Stabilimax NZ® device in early 2007. The multi-center, randomized, controlled clinical trial compares posterior dynamic stabilization using the Stabilimax NZ® Dynamic Spine Stabilization System to patients receiving traditional fusion stabilization to treat degenerative lumbar spinal stenosis. A total of 266 Stabilimax NZ® patients and 133 control patients across 20 different sites are to be enrolled in the trial. Applied Spine faced a challenge familiar to that faced by other medical device companies conducting clinical trials: Because the participating investigators are spread out across 20 sites, efficient communication between the parties is problematic.
Typically, Principal Investigators (PIs)1 collect the patient data submitted by the surgeon investigators and meet one to two times a year to go through the patient cases post-operatively