Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery With Titanium Implants
SALLY
SALLY
Sponsor study identifier
interventional
51
1 country
11
Study Start
October 3, 2017
Actual (reported)Primary Completion
June 19, 2024
Actual (reported)Study Completion
June 19, 2024
Actual (reported)SALLY studies sacroiliac joint fusion with the iFuse-3D implant.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 19, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 18, 2017
Actual (reported)April 21, 2017
Actual (reported)October 3, 2017
Actual (reported)June 19, 2024
Actual (reported)June 19, 2024
Actual (reported)Primary Radiographic Outcome: Bone adherence
Percent surface area of the sacral end of the implants to which bone is adherent.
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
Comparing baseline to 6 months.
Bridging Bone
6 months, 12 months, and 5 years
Clinically Significant Radiolucency
6 months, 12 months, and 5 years
Adverse Bone Reactions
6 months, 12 months, and 5 years
Positive Bone Remodeling
6 months, 12 months, and 5 years
SIJ Pain
Baseline, 3 mo, 6 mo, 12 mo, 24 mo, 60 months.
These subjects will get pelvic CT at 6 months post-operatively.
These subjects will get pelvic CT at 12 months post-operatively.
Minimally invasive SIJ fusion with iFuse-3D titanium implant (usually 3 implants per SIJ).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Memorial Orthopaedic Surgical Group
Long Beach, California, 90806, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Clin Tech Center for Spine Health
Johnstown, Colorado, 80534, United States
The B.A.C.K. Center
Melbourne, Florida, 32901, United States
Orthopedic Center of Southern Illinois
Mount Vernon, Illinois, 62864, United States
Bluegrass Orthopaedics
Lexington, Kentucky, 40509, United States
LSU Health Sciences Center, Department of Neurosurgery
Dat KO, Cher D, Polly DW. Effects of BMI on SI joint fusion outcomes: examining the evidence to improve insurance guidelines. Spine J. 2024 May;24(5):783-790. doi: 10.1016/j.spinee.2023.11.015. Epub 2023 Dec 9.
Daniel J Cher, MD
SI-BONE, Inc.
51 participants (actual enrollment reported by the registry).
First Submitted
April 18, 2017
First Posted
April 21, 2017
Study Start
October 3, 2017
Actual (reported)COMBINATION OF LATISSIMUS DORSI AND GLUTEAL STRENGTHENING IN SACROILIAC DYSFUNCTION
Contact the study team to confirm eligibility.
New Orleans, Louisiana, 70112, United States
Columbia Orthopaedic Group
Columbia, Missouri, 65201, United States
South Oregon Orthopedics
Medford, Oregon, 97504, United States
Overlake Hospital Medical Center
Bellevue, Washington, 98004, United States
Aurora Research Institute
Green Bay, Wisconsin, 54311, United States
Primary Completion
June 19, 2024
Actual (reported)Study Completion
June 19, 2024
Actual (reported)Last Updated
June 5, 2025
Record last verified: 2025-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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