Official Title

SIJ Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial

Purpose

To determine whether placement of iFuse-3D across the ssacroiliac joint (SIJ) in the Bedrock configuration provides
clinical and/or radiographic benefits in patients undergoing multilevel spine fusion (MLF) surgery with fixation to the pelvis

Could this study be right for you?

You may be eligible for this study if you are:
1. Age 21-75 at time of screening
2. Scheduled for multilevel (4 or more levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
3. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion Criteria
1. The reason for your multilevel spine fusion surgery is any of the following:
a. Congenital neuromuscular disease
b. Prior pelvic fixation (already have S2AI or iliac bolts in place, current surgery indicated to revise this hardware)
c. Grade IV spondylolisthesis
2. Prior sacroiliac joint fusion/fixation on either side
3. Presence of spinal cord stimulator
4. Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery
5. Surgeon plans to use iliac screw for pelvic fixation
6. Severe osteoporosis
7. Known allergy to titanium or titanium alloys
8. Current local or systemic infection that raises the risk of surgery
9. Currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the SIJ or low back pain.
10. Currently pregnant or planning pregnancy in the next 2 years
11. Known or suspected drug or alcohol abuse
12. Fibromyalgia

Age Range

21 and up