SI Joint Stabilization in Long Fusion to the Pelvis

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 213

Inclusion 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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion with S2AI screw abnormality on CT scan;Incidence of SI Joint pain;Change from baseline in self-reported SI joint pain at 2 years

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects requiring revision, removal, reoperation or supplemental fixation;Therapeutic injection or other non-medication based intervention;Oswestry Disability Index;EuroQol Group Health Questionnaire;Scoliosis Research Society 22r Patient Questionnaire;Ambulatory and Work Status;Opioid Medication Use;Proportion of S2AI screw breakage;Proportion of S2AI screw loosening;iFuse-3D implant fully seated;iFuse-3D implant position;Proportion of abnormal bone reactions in the pelvis;Change from baseline thoracic kyphosis at 2 years;Change from baseline pelvic tilt at 2 years;Change from baseline pelvic incidence at 2 years

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