SIJ Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial
This clinical trial is seeking to enroll patients with curved spines or other anatomic spinal problems. The goal of this trial is to determine whether placing a device, called iFuse-3D, into the sacrum and ilium (pelvis) bone during multilevel spine fusion (MLF) surgery provides benefits compared to not using this device. During MLF surgery, a spine surgeon places rods and screws in the spine in an attempt to straighten the spine and correct other spinal problems. The surgeon also places screws into the sacrum and pelvis bone. This may result in a decrease in pain and a restoration of the normal curvature of the spine. This is a multicenter trial with up to 35 hospitals in the US, Europe, and Australia. This study hopes to enroll 220 patients. If you participate, the study requires you to participate for two years with in-person visits between 2-6 weeks post-operation and at 6, 12 and 24 months.
To determine whether placement of iFuse-3D across the SIJ in the edrock configuration provides clinical and/or radiographic benefits in patients undergoing MLF surgery with fiation to the pelvis.
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
1. Age 21-75 at time of screening
2. Patient scheduled for multilevel (4 or more levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
3. Patient has signed study-specific informed consent form
4. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the
contact information above or email email@example.com and someone will assist you.
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in the aforementioned ways, please contact firstname.lastname@example.org.