SI Joint Stabilization in Long Fusion to the Pelvis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sacroiliac Joint Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial

Conditions
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Sacroiliac Joint Disruption, Scoliosis Lumbar Region

Intervention / Treatment
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* Device: iFuse 3-D in Bedrock Configuration
* Procedure: Multilevel Lumbar Fusion surgery


Participation Criteria
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Eligibility Criteria
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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: Congenital neuromuscular disease Prior pelvic fixation (i.e., patient already has S2AI or iliac bolts in place, current surgery indicated to revise this hardware) 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>Multilevel Lumbar Fusion Surgery | Procedure: Multilevel Lumbar Fusion surgery<br>* Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.<br>|
| Experimental: Standard Care + iFuse 3-D<br>Multilevel Lumbar Fusion Surgery with additional placement of iFuse 3-D in a trajectory parallel to the S2AI screws | Device: iFuse 3-D in Bedrock Configuration<br>* Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed, additionally iFuse 3-D implants are placed in a trajectory parallel to the S2AI screws.<br>Procedure: Multilevel Lumbar Fusion surgery<br>* Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion with S2AI screw abnormality on CT scan | Proportion of subjects with any of following: S2AI screw breakage, loosening or pullout OR rod breakage distal to S1 on 2-year CT scan as interpreted by an independent bone radiologist | 2 years | 
| Incidence of SI Joint pain | Proportion of subjects without SI joint pain at baseline who develop new onset SI joint pain by 2 years | 2 years | 
| Change from baseline in self-reported SI joint pain at 2 years | Change from baseline in self-reported SI joint pain on a 0 (no pain) -10 (worst imaginable pain) visual analog scale | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects requiring revision, removal, reoperation or supplemental fixation | Proportion of subjects requiring revision, removal, reoperation or supplemental fixation related to S2AI screws or iFuse-3D | 2 years | 
| Therapeutic injection or other non-medication based intervention | Proportion of subjects requiring therapeutic injection or other non-medication based intervention to treat SI joint pain | 2 years | 
| Oswestry Disability Index | Change from baseline in self reported Oswestry Disability Index (ODI) score at 2 years | 2 years | 
| EuroQol Group Health Questionnaire | Change from baseline in self reported EuroQol Group Health Questionnaire with Time Trade Off Utility Index (EQ-5D TTO index) score at 2 years | 2 years | 
| Scoliosis Research Society 22r Patient Questionnaire | Change from baseline in self reported Scoliosis Research Society 22r Patient Questionnaire (SRS-22R) score at 2 years | 2 years | 
| Ambulatory and Work Status | Change from baseline in self reported ambulatory and work status at 2 years | 2 years | 
| Opioid Medication Use | Change from baseline opioid medications used, i.e., the mean daily dose during 2 weeks prior to each visit | 2 years | 
| Proportion of S2AI screw breakage | Proportion of S2AI screws with any breakage over the course of the study on CT scan as interpreted by an independent bone radiologist | 2 years | 
| Proportion of S2AI screw loosening | Proportion of S2AI screws with any loosening over the course of the study on CT scan as interpreted by an independent bone radiologist | 2 years | 
| iFuse-3D implant fully seated | Proportion of iFuse-3D implants placed fully seated (at least 20mm) into the sacrum on 2-year CT scan as interpreted by an independent bone radiologist | 2 years | 
| iFuse-3D implant position | Proportion of iFuse-3D implants with malposition (distal end outside of ilium) on 2-year CT scan as interpreted by an independent bone radiologist | 2 years | 
| Proportion of abnormal bone reactions in the pelvis | Proportion of abnormal bone reactions in the pelvis at either the iFuse-3D implant or S2AI screw on 2-year CT scan as interpreted by an independent bone radiologist | 2 years | 
| Change from baseline thoracic kyphosis at 2 years | Change from baseline thoracic kyphosis on 2-year CT scan as interpreted by an independent bone radiologist | 2 years | 
| Change from baseline pelvic tilt at 2 years | Change from baseline pelvic tilt on 2-year CT scan as interpreted by an independent bone radiologist | 2 years | 
| Change from baseline pelvic incidence at 2 years | Change from baseline pelvic incidence on 2-year CT scan as interpreted by an independent bone radiologist | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult Scoliotic Spinal Deformity, Sacroiliac joint pain, multilevel lumbar surgery, SI Joint pain