Infuse Bone Graft
Condition: Degenerative disease of the lumbosacral spine
Key Inclusion Criteria:
- Radiographic evidence of degenerative disease of the lumbosacral spine
- History of low back pain
- At least 18 years old and skeletally mature at the time of surgery
Key Exclusion Criteria:
- Prior surgical procedure at the involved or adjacent spinal levels
- Significant lumbar instability
- Planned use of an internal or external bone growth stimulator
Full Study Name
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 Treatment of Symptomatic Degenerative Disease of the Lumbosacral Spine (IRB no. 0000290
This study focuses on individuals who have been diagnosed with degenerative disc disease at one or more levels of their spine and who have not responded to non-surgical treatments. The purpose of the study is to evaluate the investigational use of the Infuse Bone Graft in combination with the Capstone Spinal System (a spinal spacer device) and an implantable, metal rod and screw system plus autograft bone (the patient’s own bone) to determine whether it is safe and effective when used in a transforaminal lumbar interbody fusion (TLIF) surgery. TLIF is a surgical procedure to make two or three vertebrae grow together (fuse).
The Infuse Bone Graft consists of a man-made version of the BMP-2 protein, which is a protein that occurs naturally in humans and has been shown to help with forming bone.