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

NCT02270203 | Completed

• 1 other identifier: 300244
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 12

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

Conditions

Degenerative Sacroilitis; Sacroiliac Joint Disruption

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• VAS (Visual Analog Scale)

  3 years on LOIS (5 years post-op)

• Oswestry Disability Index (ODI) Questionnaire

  3 years on LOIS (5 years post-op)

• Improvement in quality of life (QOL)

  3 years on LOIS (5 years post-op)

• non-working subjects returning to work

  3 years on LOIS (5 years post-op)

• CT scans showing bridging bone

  3 years on LOIS (5 years post-op)

Interventions

Pelvic CT at 5 years post-op RADIATION

Pelvic CT at 5 years post-op

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SI-BONE, Inc.: lead

Study Sites (12)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Regenerative Orthopaedics and Spine Institute

Stockbridge, Georgia, 30281, United States

Location

Orthopaedic Center of Southern Illinois

Mount Vernon, Illinois, 62864, United States

Location

Bluegrass Orthopaedics & Hand Care

Lexington, Kentucky, 40509, United States

Location

Columbia Orthopaedic Group

Columbia, Missouri, 65201, United States

Location

Oklahoma Center for Spine & Pain Solutions

Oklahoma City, Oklahoma, 73159, United States

Location

Allegheny Medical Center

Pittsburgh, Pennsylvania, 15212, United States

Location

MUSC

Charleston, South Carolina, 29425, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

Overlake Hospital Medical Center

Bellevue, Washington, 98004, United States

Location

Aurora Research Institute

Green Bay, Wisconsin, 54311, United States

Location

Integrated Spine Care

Wauwatosa, Wisconsin, 53132, United States

Location

Related Publications (1)

• 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.

  PMID: 30214322 DERIVED

Study Officials

• Daniel Cher, MD

  SI-BONE, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 21, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 6, 2019

Record last verified: 2019-08

Locations

US (12)