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
103 participants
OBSERVATIONAL
2014-10-31
2019-07-31
Brief Summary
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Study Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System). The two ongoing trials are:
* SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement, and
* INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the same patient population who underwent either non-surgical treatment or iFuse placement
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Pelvic CT at 5 years post-op
Pelvic CT at 5 years post-op
Eligibility Criteria
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Inclusion Criteria
2. Patient has signed study-specific LOIS informed consent form.
3. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.
Exclusion Criteria
2. Currently pregnant or planning pregnancy within 5 years of iFuse Implant.
3. Patient is a prisoner or a ward of the state.
4. Known or suspected active drug or alcohol abuse.
5. Inadequately treated psychiatric illness (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
6. Unwilling to perform the long-term follow up requirements of this study.
7. Patient has any condition that could substantially prevent long-term follow-up.
8. Unwilling to return to site at pre-specified study visits.
21 Years
70 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, Inc.
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Regenerative Orthopaedics and Spine Institute
Stockbridge, Georgia, United States
Orthopaedic Center of Southern Illinois
Mount Vernon, Illinois, United States
Bluegrass Orthopaedics & Hand Care
Lexington, Kentucky, United States
Columbia Orthopaedic Group
Columbia, Missouri, United States
Oklahoma Center for Spine & Pain Solutions
Oklahoma City, Oklahoma, United States
Allegheny Medical Center
Pittsburgh, Pennsylvania, United States
MUSC
Charleston, South Carolina, United States
Precision Spine Care
Tyler, Texas, United States
Overlake Hospital Medical Center
Bellevue, Washington, United States
Aurora Research Institute
Green Bay, Wisconsin, United States
Integrated Spine Care
Wauwatosa, Wisconsin, United States
Countries
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References
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Darr E, Cher D. Four-year outcomes after minimally invasive transiliac sacroiliac joint fusion with triangular titanium implants. Med Devices (Auckl). 2018 Aug 29;11:287-289. doi: 10.2147/MDER.S179003. eCollection 2018.
Other Identifiers
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300244
Identifier Type: -
Identifier Source: org_study_id
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