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

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

Study Overview

• Status: Completed
• Conditions: Sacroiliac Joint Disruption; Degenerative Sacroilitis
• Intervention / Treatment: Radiation: Pelvic CT at 5 years post-op

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Regenerative Orthopaedics and Spine Institute
  • Illinois
    • Mount Vernon, Illinois, United States, 62864
      • Orthopaedic Center of Southern Illinois
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Orthopaedics & Hand Care
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Orthopaedic Group
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73159
      • Oklahoma Center for Spine & Pain Solutions
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC
  • Texas
    • Tyler, Texas, United States, 75701
      • Precision Spine Care
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Hospital Medical Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54311
      • Aurora Research Institute
    • Wauwatosa, Wisconsin, United States, 53132
      • Integrated Spine Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement.

Description

Inclusion Criteria:

1. 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.
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:

1. Treated with iFuse as a "crossover" in INSITE.
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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SI-BONE, Inc.
• Investigators: Study Director: Daniel Cher, MD, SI-BONE, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: October 16, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: si joint; si joint pain; si joint injury; si joint treatment; si joint injections; si joint inflammation; si joint problems; si joint symptoms; 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; hypermobile joint
• Other Study ID Numbers: 300244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED