Trial Number
253-22
Conditions
Herniated Disk, Spinal stenosis, Spondylolisthesis
Participant Age Range
21 years and older
Participant Gender
Any
Enrolling Participants
Yes
Overview
“A Prospective, Randomized, Multi-Center, Open-Label Study of Infuse Bone Graft with Mastergraft Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions”
The purpose of this study is to obtain safety and effectiveness data on the investigational device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use in this indication. The study information may be used for a potential pivotal study design.