SI Joint Stabilization in Long Fusion to the Pelvis

Launched by SI-BONE, INC. · Aug 19, 2019

Keywords

ClinConnect Summary

This is a multicenter randomized controlled, postmarket clinical study to determine the differences between subjects undergoing standard MLF surgery with S2AI fixation in the pelvis vs the additional placement of iFuse 3-D in the bedrock configuration during MLF surgery. Subjects will be monitored for sacroiliac (SI) joint pain and at two years post surgery a CT scan will be taken to assess S2AI screw loosening or any other findings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 21-75 at time of screening
• • 2. Patient scheduled for multilevel (\>3 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
• Exclusion Criteria:
• 1. 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
• • 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. Any known sacral or iliac pathology
• • 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. 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.
• • 15. Currently pregnant or planning pregnancy in the next 2 years
• • 16. Prisoner or a ward of the state.
• • 17. Known or suspected drug or alcohol abuse
• • 18. Uncontrolled psychiatric disease that could interfere with study participation
• • 19. Fibromyalgia