Prospective Randomized Controlled Blinded Pivotal Study in Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) at One or Two Levels Using Infuse Bone Graft and The Capstone Spinal System with Posterior Supplemental Fixation for the Trea

Brief description of study

The purpose of this study is to evaluate the use of Infuse™ Bone Graft in combination with the Capstone™ Spinal System and other hardware in transformaninal lumbar interbody fusion (TLIF) surgeries. Infuse™ Bone Graft is a protein that is used to help grow bone in fusion surgeries. The Capstone™ Spinal System is the brand name for the set of hardware (rods and screws) that would be used in the fusion surgeries for this study. TLIF surgeries are performed on the lower back to fuse one of more vertebrae together with goal of relieving symptoms that are interfering with everyday life.Two different amounts of the Infuse™ Bone Graft material will be implanted in your back to see if they help with bone fusion. The Infuse Bone Graft is considered investigational in this study because it has not been approved for use in this in type of surgery.


Clinical Study Identifier: s20-00118
ClinicalTrials.gov Identifier: NCT04073563
Principal Investigator: Themistocles Protopsaltis.
Other Investigators: Yong H Kim, Charla R Fischer, Peter G. Passias.


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