LOIS: Long-Term Follow-Up in INSITE/SIFI
- Conditions
- Sacroiliac Joint DisruptionDegenerative Sacroilitis
- Registration Number
- NCT02270203
- Lead Sponsor
- SI-BONE, Inc.
- 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 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subject Success 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 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.
- Secondary Outcome Measures
Name Time Method CT scans showing bridging bone 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 3 years on LOIS Occurrence rate of serious adverse events.
VAS (Visual Analog Scale) 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 3 years on LOIS (5 years post-op) Improvement in Oswestry Disability Index (ODI) at follow-up visits.
Improvement in quality of life (QOL) 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 3 years on LOIS (5 years post-op) Proportion of non-working subjects who return to work
Trial Locations
- Locations (12)
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
MUSC
🇺🇸Charleston, South Carolina, United States
Integrated Spine Care
🇺🇸Wauwatosa, Wisconsin, United States
Allegheny Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Regenerative Orthopaedics and Spine Institute
🇺🇸Stockbridge, Georgia, United States
Orthopaedic Center of Southern Illinois
🇺🇸Mount Vernon, Illinois, United States
Columbia Orthopaedic Group
🇺🇸Columbia, Missouri, United States
Oklahoma Center for Spine & Pain Solutions
🇺🇸Oklahoma City, Oklahoma, United States
Bluegrass Orthopaedics & Hand Care
🇺🇸Lexington, Kentucky, 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