Status:
COMPLETED
LOIS: Long-Term Follow-Up in INSITE/SIFI
Lead Sponsor:
SI-BONE, Inc.
Conditions:
Degenerative Sacroilitis
Sacroiliac Joint Disruption
Eligibility:
All Genders
21-70 years
Brief Summary
The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac join...
Eligibility Criteria
Inclusion
- Patient enrolled and treated in SIFI or patient initially randomized to iFuse and treated in INSITE. Note: Patient may be in the initial follow up period associated with SIFI or INSITE at the same time they consent for this study and "extend" their post-operative follow up.
- Patient has signed study-specific LOIS informed consent form.
- Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.
Exclusion
- Treated with iFuse as a "crossover" in INSITE.
- Currently pregnant or planning pregnancy within 5 years of iFuse Implant.
- Patient is a prisoner or a ward of the state.
- Known or suspected active drug or alcohol abuse.
- Inadequately treated psychiatric illness (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
- Unwilling to perform the long-term follow up requirements of this study.
- Patient has any condition that could substantially prevent long-term follow-up.
- Unwilling to return to site at pre-specified study visits.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT02270203
Start Date
October 1 2014
End Date
July 1 2019
Last Update
August 6 2019
Active Locations (12)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
2
Regenerative Orthopaedics and Spine Institute
Stockbridge, Georgia, United States, 30281
3
Orthopaedic Center of Southern Illinois
Mount Vernon, Illinois, United States, 62864
4
Bluegrass Orthopaedics & Hand Care
Lexington, Kentucky, United States, 40509