SI Joint Stabilization in Long Fusion to the Pelvis
- Conditions
- Scoliosis Lumbar RegionSacroiliac Joint Disruption
- Interventions
- Device: iFuse 3-D in Bedrock ConfigurationProcedure: Multilevel Lumbar Fusion surgery
- Registration Number
- NCT04062630
- Lead Sponsor
- SI-BONE, Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care + iFuse 3-D Multilevel Lumbar Fusion surgery Multilevel Lumbar Fusion Surgery with additional placement of iFuse 3-D in a trajectory parallel to the S2AI screws Standard care Multilevel Lumbar Fusion surgery Multilevel Lumbar Fusion Surgery Standard Care + iFuse 3-D iFuse 3-D in Bedrock Configuration Multilevel Lumbar Fusion Surgery with additional placement of iFuse 3-D in a trajectory parallel to the S2AI screws
- Primary Outcome Measures
Name Time Method Change from baseline in self-reported SI joint pain at 2 years 2 years Change from baseline in self-reported SI joint pain on a 0 (no pain) -10 (worst imaginable pain) visual analog scale
Incidence of SI Joint pain 2 years Proportion of subjects without SI joint pain at baseline who develop new onset SI joint pain by 2 years
Proportion with S2AI screw abnormality on CT scan 2 years 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
- Secondary Outcome Measures
Name Time Method Proportion of subjects requiring revision, removal, reoperation or supplemental fixation 2 years Proportion of subjects requiring revision, removal, reoperation or supplemental fixation related to S2AI screws or iFuse-3D
Therapeutic injection or other non-medication based intervention 2 years Proportion of subjects requiring therapeutic injection or other non-medication based intervention to treat SI joint pain
Scoliosis Research Society 22r Patient Questionnaire 2 years Change from baseline in self reported Scoliosis Research Society 22r Patient Questionnaire (SRS-22R) score at 2 years
Change from baseline thoracic kyphosis at 2 years 2 years Change from baseline thoracic kyphosis on 2-year CT scan as interpreted by an independent bone radiologist
Change from baseline pelvic incidence at 2 years 2 years Change from baseline pelvic incidence on 2-year CT scan as interpreted by an independent bone radiologist
Oswestry Disability Index 2 years Change from baseline in self reported Oswestry Disability Index (ODI) score at 2 years
EuroQol Group Health Questionnaire 2 years Change from baseline in self reported EuroQol Group Health Questionnaire with Time Trade Off Utility Index (EQ-5D TTO index) score at 2 years
Ambulatory and Work Status 2 years Change from baseline in self reported ambulatory and work status at 2 years
Opioid Medication Use 2 years Change from baseline opioid medications used, i.e., the mean daily dose during 2 weeks prior to each visit
Proportion of S2AI screw breakage 2 years Proportion of S2AI screws with any breakage over the course of the study on CT scan as interpreted by an independent bone radiologist
Proportion of S2AI screw loosening 2 years Proportion of S2AI screws with any loosening over the course of the study on CT scan as interpreted by an independent bone radiologist
Proportion of abnormal bone reactions in the pelvis 2 years 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
iFuse-3D implant fully seated 2 years 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
iFuse-3D implant position 2 years Proportion of iFuse-3D implants with malposition (distal end outside of ilium) on 2-year CT scan as interpreted by an independent bone radiologist
Change from baseline pelvic tilt at 2 years 2 years Change from baseline pelvic tilt on 2-year CT scan as interpreted by an independent bone radiologist
Trial Locations
- Locations (31)
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Austin Spine
🇺🇸Austin, Texas, United States
Texas Back Institute
🇺🇸Plano, Texas, United States
Ortho Virginia Research Institute
🇺🇸Richmond, Virginia, United States
Klinikum Magdeburg
🇩🇪Magdeburg, Germany
Scripps Hospital
🇺🇸La Jolla, California, United States
Keck School of Medicine of USC
🇺🇸Los Angeles, California, United States
University of Virginia - Dept of Neurosurgery
🇺🇸Charlottesville, Virginia, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Royal National Orthopaedic Hospital
🇬🇧Stanmore, United Kingdom
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
St Mary's Medical Center
🇺🇸San Francisco, California, United States
Parkview Regional Medical Center
🇺🇸Fort Wayne, Indiana, United States
Axis Spine Center
🇺🇸Coeur d'Alene, Idaho, United States
University of Buffalo Neurosurgery
🇺🇸Buffalo, New York, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
OrthoCarolina Research Institute
🇺🇸Charlotte, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Tennessee Orthopaedics Alliance
🇺🇸Nashville, Tennessee, United States
UVA Spine Center - Ortho
🇺🇸Charlottesville, Virginia, United States
North Texas Neurosurgical and Spine Center
🇺🇸Fort Worth, Texas, United States
Epworth HealthCare
🇦🇺Richmond, Victoria, Australia
Ospedale Civile di Legnano- ASST Ovest Milanese
🇮🇹Legnano, Milan, Italy
Virginia Mason
🇺🇸Seattle, Washington, United States
Orlando Health Physician Neurosurgery Group
🇺🇸Orlando, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States