SI Joint Stabilization in Long Fusion to the Pelvis

Completed · Not applicable

Conditions studied: Sacroiliac Joint Disruption, Scoliosis Lumbar Region

In brief

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.

Key facts

Study ID

NCT04062630

Run by

SI-BONE, Inc.

People needed

213

Starts

2020-05-20

Expected to finish

2025-01-15

Last updated by the study team

2025-02-18

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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