LOIS: Long-Term Follow-Up in INSITE/SIFI (LOIS)
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|ClinicalTrials.gov Identifier: NCT02270203|
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : August 6, 2019
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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 joint disruptions (SD).
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
|Condition or disease||Intervention/treatment|
|Degenerative Sacroilitis Sacroiliac Joint Disruption||Radiation: Pelvic CT at 5 years post-op|
|Study Type :||Observational|
|Actual Enrollment :||103 participants|
|Official Title:||LOIS: Long-Term Follow-Up in INSITE/SIFI|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||July 2019|
|Actual Study Completion Date :||July 2019|
- Radiation: Pelvic CT at 5 years post-op
Pelvic CT at 5 years post-op
- Subject Success [ Time Frame: 3 years on LOIS (5 years post-op) ]Composite endpoint of success defined as improvement in VAS (Visual Analog Scale) recorded at SIFI or INSITE Baseline VAS back pain score by ≥20 mm; Absence of device-related SAE (Serious Adverse Events) ; Absence of neurological worsening related to the sacral spine,& Absence of surgical re-intervention on the target SI joint(s).
- Radiographic (CT) apposition of bone to sacral and iliac sides of implant [ Time Frame: 3 years on LOIS (5 years post-op) ]Proportion of subjects (with CT) who had at least 30% apposition of bone to sacral and iliac sides in at least 2 of 3 iFuse implants.
- VAS (Visual Analog Scale) [ Time Frame: 3 years on LOIS (5 years post-op) ]Improvement in VAS (Visual Analog Scale), SI joint pain at follow-up visits.
- Oswestry Disability Index (ODI) Questionnaire [ Time Frame: 3 years on LOIS (5 years post-op) ]Improvement in Oswestry Disability Index (ODI) at follow-up visits.
- Improvement in quality of life (QOL) [ Time Frame: 3 years on LOIS (5 years post-op) ]Improvement in quality of life as measure by EQ-5D Questionnaire at follow-up visits.
- non-working subjects returning to work [ Time Frame: 3 years on LOIS (5 years post-op) ]Proportion of non-working subjects who return to work
- CT scans showing bridging bone [ Time Frame: 3 years on LOIS (5 years post-op) ]Proportion of CT scans that show bridging bone across the SI joint at 5 years post-operatively
- SAE (Serious Adverse Events) occurrence rate [ Time Frame: 3 years on LOIS ]Occurrence rate of serious adverse events.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||21 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270203
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06510|
|United States, Georgia|
|Regenerative Orthopaedics and Spine Institute|
|Stockbridge, Georgia, United States, 30281|
|United States, Illinois|
|Orthopaedic Center of Southern Illinois|
|Mount Vernon, Illinois, United States, 62864|
|United States, Kentucky|
|Bluegrass Orthopaedics & Hand Care|
|Lexington, Kentucky, United States, 40509|
|United States, Missouri|
|Columbia Orthopaedic Group|
|Columbia, Missouri, United States, 65201|
|United States, Oklahoma|
|Oklahoma Center for Spine & Pain Solutions|
|Oklahoma City, Oklahoma, United States, 73159|
|United States, Pennsylvania|
|Allegheny Medical Center|
|Pittsburgh, Pennsylvania, United States, 15212|
|United States, South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|Precision Spine Care|
|Tyler, Texas, United States, 75701|
|United States, Washington|
|Overlake Hospital Medical Center|
|Bellevue, Washington, United States, 98004|
|United States, Wisconsin|
|Aurora Research Institute|
|Green Bay, Wisconsin, United States, 54311|
|Integrated Spine Care|
|Wauwatosa, Wisconsin, United States, 53132|
|Study Director:||Daniel Cher, MD||SI-BONE, Inc.|
|Responsible Party:||SI-BONE, Inc.|
|Other Study ID Numbers:||
|First Posted:||October 21, 2014 Key Record Dates|
|Last Update Posted:||August 6, 2019|
|Last Verified:||August 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
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