SALLY studies sacroiliac joint fusion with the iFuse-3D implant.
Participants will all get sacroiliac joint fusion on this study using the iFuse-3D titanium implant, manufactured by SI-BONE, Inc. Participants will be followed for clinical outcomes at pre-planned time points on the trial. Participants will be randomized to CT scan at 6 months or 12 months, and all will also get a CT scan at 5 years, the final visit for the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Minimally invasive SIJ fusion with iFuse-3D titanium implant (usually 3 implants per SIJ).
Memorial Orthopaedic Surgical Group
Long Beach, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Clin Tech Center for Spine Health
Johnstown, Colorado, United States
Primary Radiographic Outcome: Bone adherence
Percent surface area of the sacral end of the implants to which bone is adherent.
Time frame: Comparing 6 and 12 month CTs to historical data from other studies.
Primary Clinical Outcome: Disability due to low back pain
Improvement in Oswestry Disability Index
Time frame: Comparing baseline to 6 months.
Bridging Bone
Proportion of treated SIJs with bridging bone.
Time frame: 6 months, 12 months, and 5 years
Clinically Significant Radiolucency
Proportion of treated SIJs with evidence of clinically significant radiolucency.
Time frame: 6 months, 12 months, and 5 years
Adverse Bone Reactions
Proportion of treated SIJs with adverse bone reactions at or near the SIJ.
Time frame: 6 months, 12 months, and 5 years
Positive Bone Remodeling
Proportion of treated SIJs with positive bone remodeling response.
Time frame: 6 months, 12 months, and 5 years
SIJ Pain
Improvement from baseline in SIJ pain as measured by Visual Analog Scale
Time frame: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months.
Disability
Improvement from baseline in disability as measured by Oswestry Disability Index.
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The B.A.C.K. Center
Melbourne, Florida, United States
Orthopedic Center of Southern Illinois
Mount Vernon, Illinois, United States
Bluegrass Orthopaedics
Lexington, Kentucky, United States
LSU Health Sciences Center, Department of Neurosurgery
New Orleans, Louisiana, United States
Columbia Orthopaedic Group
Columbia, Missouri, United States
South Oregon Orthopedics
Medford, Oregon, United States
Overlake Hospital Medical Center
Bellevue, Washington, United States
...and 1 more locations
Time frame: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months.
QOL
Improvement from baseline in QOL as measured by EQ-5D
Time frame: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months.
Physical Function
Improvement from baseline in physical function as measured by active straight leg raise, 5 times sit to stand, transitional timed up and go.
Time frame: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months.
Opioid Use
Decrease from baseline in opioid use
Time frame: Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months.
Serious Adverse Event Rate
Rate of serious adverse events related to the procedure or device.
Time frame: 3 mo, 6 mo, 12 mo, 24 mo, 60 months.