Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft With an Intervertebral Body Fusion Device and Posterior Supplemental Fixa

NCT04073563

Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft With an Intervertebral Body Fusion Device and Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine

Principal Investigator

Chetan Patel

Sponsor

Medtronic Sofamor Danek USA, Inc.

The purpose of this study is to evaluate the Infuse™ Bone Graft in combination with other spinal devices and autograft bone (your own bone) to see if it is safe and effective when used in a TLIF surgery. Two different amounts of the Infuse™ Bone Graft material will be tested.

This study is currently enrolling.