Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Sij Pain
• Age: Between 21 - 75 Years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Participants who are scheduled for multilevel (4 or more levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
  2. Participants able to provide written informed consent
  3. Participants who have the necessary mental capacity to participate and is physically able to comply with study protocol requirements

  
  

You may not be eligible for this study if the following are true:

• 1. those with the nndication for multilevel spine fusion surgery is any of the following:
     • Congenital neuromuscular disease
     • Prior pelvic fixation
     • Grade IV spondylolisthesis
  2. Participants who had 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. Any known sacral or iliac pathology
     • Sacral or iliac tumor that could prevent adequate fixation or placement
     • Sacral, iliac or SIJ infection that could prevent permanent hardware fixation
     • Acute fracture
     • Other sacral condition or anatomy for which placement of S2AI screws is typically not performed
  7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
  8. Known metabolic bone disease
  9. Severe osteoporosis
  10. Known allergy to titanium or titanium alloys
  11. Use of medications known to have detrimental effects on bone quality and soft-tissue healing
  12. Neurologic condition that would interfere with postoperative physical therapy
  13. Current local or systemic infection that raises the risk of surgery
  14. Currently receiving or seeking short- or long-term worker's compensation related to SIJ or low back pain, currently receiving disability remuneration related to SIJ or low back pain, and/or currently involved in injury litigation related to the SIJ or low back pain.
  15. Pregnant or planning pregnancy in next 2 years
  16. Prisoners or ward of the state
  17. Known or suspected drug or alcohol abuse
  18. Uncontrolled psychiatric disease that could interfere with study participation
  19. Fibromyalgia