Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
213 participants
INTERVENTIONAL
2020-05-20
2025-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard care
Multilevel Lumbar Fusion Surgery
Multilevel Lumbar Fusion surgery
Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.
Standard Care + iFuse 3-D
Multilevel Lumbar Fusion Surgery with additional placement of iFuse 3-D in a trajectory parallel to the S2AI screws
iFuse 3-D in Bedrock Configuration
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.
Multilevel Lumbar Fusion surgery
Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.
Interventions
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iFuse 3-D in Bedrock Configuration
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.
Multilevel Lumbar Fusion surgery
Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.
Eligibility Criteria
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Inclusion Criteria
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. 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
21 Years
75 Years
ALL
No
Sponsors
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SI-BONE, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Cher, MD
Role: STUDY_DIRECTOR
SI-BONE
Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Scripps Hospital
La Jolla, California, United States
University of California, San Diego
La Jolla, California, United States
Keck School of Medicine of USC
Los Angeles, California, United States
St Mary's Medical Center
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Orlando Health Physician Neurosurgery Group
Orlando, Florida, United States
Axis Spine Center
Coeur d'Alene, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Parkview Regional Medical Center
Fort Wayne, Indiana, United States
University of Michigan
Ann Arbor, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, 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
Austin Spine
Austin, Texas, United States
North Texas Neurosurgical and Spine Center
Fort Worth, Texas, United States
Texas Back Institute
Plano, Texas, United States
UVA Spine Center - Ortho
Charlottesville, Virginia, United States
University of Virginia - Dept of Neurosurgery
Charlottesville, Virginia, United States
Ortho Virginia Research Institute
Richmond, Virginia, United States
Virginia Mason
Seattle, Washington, United States
Epworth HealthCare
Richmond, Victoria, Australia
Klinikum Magdeburg
Magdeburg, , Germany
Ospedale Civile di Legnano- ASST Ovest Milanese
Legnano, Milan, Italy
Royal National Orthopaedic Hospital
Stanmore, , United Kingdom
Countries
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References
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Polly DW Jr. The Sacroiliac Joint: A Current State-of-the-Art Review. JBJS Rev. 2024 Feb 5;12(2). doi: 10.2106/JBJS.RVW.23.00151. eCollection 2024 Feb 1.
Other Identifiers
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300726
Identifier Type: -
Identifier Source: org_study_id
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