LOIS: Long-Term Follow-Up in INSITE/SIFI

Study Overview
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Brief Summary
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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

Official Title
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LOIS: Long-Term Follow-Up in INSITE/SIFI

Conditions
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Degenerative Sacroilitis, Sacroiliac Joint Disruption

Intervention / Treatment
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* Radiation: Pelvic CT at 5 years post-op


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Pelvic CT at 5 years post-op|Pelvic CT at 5 years post-op|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Success | 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). | 3 years on LOIS (5 years post-op) | 
| Radiographic (CT) apposition of bone to sacral and iliac sides of implant | 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. | 3 years on LOIS (5 years post-op) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (Visual Analog Scale) | Improvement in VAS (Visual Analog Scale), SI joint pain at follow-up visits. | 3 years on LOIS (5 years post-op) | 
| Oswestry Disability Index (ODI) Questionnaire | Improvement in Oswestry Disability Index (ODI) at follow-up visits. | 3 years on LOIS (5 years post-op) | 
| Improvement in quality of life (QOL) | Improvement in quality of life as measure by EQ-5D Questionnaire at follow-up visits. | 3 years on LOIS (5 years post-op) | 
| non-working subjects returning to work | Proportion of non-working subjects who return to work | 3 years on LOIS (5 years post-op) | 
| CT scans showing bridging bone | Proportion of CT scans that show bridging bone across the SI joint at 5 years post-operatively | 3 years on LOIS (5 years post-op) | 
| SAE (Serious Adverse Events) occurrence rate | Occurrence rate of serious adverse events. | 3 years on LOIS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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si joint, si joint injury, si joint treatment, si joint inflammation, si joint problems, si joint symptoms, hypermobile joint, si joint arthritis, si joint pain treatment, inflamed si joint, si joint sclerosis, locked si joint, si joint injuries, si joint disease, si joint infection, sacroiliac joint pelvic pain, sacroiliac joint arthritis treatment, si joint pain, si joint injections