SI Joint Stabilization in Long Fusion to the Pelvis


About this study

The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 21-75 at time of screening.
  • Patient scheduled for multilevel (> 3 levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws.
  • Patient has signed study-specific informed consent form.
  • Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements. 

Exclusion Criteria:

  • Indication for multilevel spine fusion surgery is any of the following: 1. Congenital neuromuscular disease 2. Prior pelvic fixation (i.e., patient already has S2AI or iliac bolts in place, current surgery indicated to revise this hardware) 3. Grade IV spondylolisthesis.
  • Prior sacroiliac joint fusion/fixation on either side.
  • Presence of spinal cord stimulator.
  • Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery.
  • Surgeon plans to use iliac screw for pelvic fixation.
  • Any known sacral or iliac pathology.
  • Any condition or anatomy that makes treatment with the iFuse Implant System infeasible.
  • Known metabolic bone disease.
  • Severe osteoporosis.
  • Known allergy to titanium or titanium alloys.
  • Use of medications known to have detrimental effects on bone quality and soft-tissue healing.
  • Neurologic condition that would interfere with postoperative physical therapy.
  • Current local or systemic infection that raises the risk of surgery.
  • Patient currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the SI joint or low back pain.
  • Currently pregnant or planning pregnancy in the next 2 years.
  • Prisoner or a ward of the state.
  • Known or suspected drug or alcohol abuse.
  • Uncontrolled psychiatric disease that could interfere with study participation.
  • Fibromyalgia.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Benjamin Elder, M.D., Ph.D.

Open for enrollment

Contact information:

Jingfei Cheng M.D.

(507) 293-7354

More information


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