SI Joint Stabilization in Long Fusion to the Pelvis (SILVIA)

February 14, 2025 updated by: SI-BONE, Inc.

Sacroiliac Joint Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial

The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multicenter randomized controlled, postmarket clinical study to determine the differences between subjects undergoing standard MLF surgery with S2AI fixation in the pelvis vs the additional placement of iFuse 3-D in the bedrock configuration during MLF surgery. Subjects will be monitored for sacroiliac (SI) joint pain and at two years post surgery a CT scan will be taken to assess S2AI screw loosening or any other findings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
213

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Richmond, Victoria, Australia, 3121
        • Epworth Healthcare
  • Germany
      • Magdeburg, Germany, 39130
        • Klinikum Magdeburg
  • Italy
    • Milan
      • Legnano, Milan, Italy, 20025
        • Ospedale Civile di Legnano- ASST Ovest Milanese
  • United Kingdom
      • Stanmore, United Kingdom, HA7 4LP
        • Royal National Orthopaedic Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • La Jolla, California, United States, 92037
        • University of California, San Diego
      • La Jolla, California, United States, 92037
        • Scripps Hospital
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine of USC
      • San Francisco, California, United States, 94117
        • St Mary's Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health Physician Neurosurgery Group
    • Idaho
      • Coeur d'Alene, Idaho, United States, 82815
        • Axis Spine Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Regional Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • Buffalo, New York, United States, 14203
        • University of Buffalo Neurosurgery
      • New York, New York, United States, 10027
        • Hospital for Special Surgery
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Research Institute
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Tennessee Orthopaedics Alliance
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Spine
      • Fort Worth, Texas, United States, 76104
        • North Texas Neurosurgical and Spine Center
      • Plano, Texas, United States, 75093
        • Texas Back Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVA Spine Center - Ortho
      • Charlottesville, Virginia, United States, 22908-0212
        • University of Virginia - Dept of Neurosurgery
      • Richmond, Virginia, United States, 23235
        • Ortho Virginia Research Institute
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 21-75 at time of screening
  2. Patient scheduled for multilevel (>3 levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
  3. Patient has signed study-specific informed consent form
  4. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion Criteria:

  1. Indication for multilevel spine fusion surgery is any of the following:

    1. Congenital neuromuscular disease
    2. Prior pelvic fixation (i.e., patient already has S2AI or iliac bolts in place, current surgery indicated to revise this hardware)
    3. Grade IV spondylolisthesis
  2. Prior sacroiliac joint fusion/fixation on either side
  3. Presence of spinal cord stimulator
  4. Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery
  5. Surgeon plans to use iliac screw for pelvic fixation
  6. Any known sacral or iliac pathology
  7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
  8. Known metabolic bone disease
  9. Severe osteoporosis
  10. Known allergy to titanium or titanium alloys
  11. Use of medications known to have detrimental effects on bone quality and soft-tissue healing
  12. Neurologic condition that would interfere with postoperative physical therapy
  13. Current local or systemic infection that raises the risk of surgery
  14. Patient currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the SI joint or low back pain.
  15. Currently pregnant or planning pregnancy in the next 2 years
  16. Prisoner or a ward of the state.
  17. Known or suspected drug or alcohol abuse
  18. Uncontrolled psychiatric disease that could interfere with study participation
  19. Fibromyalgia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard care
Multilevel Lumbar Fusion Surgery
Procedure: Multilevel Lumbar Fusion surgery
Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.
Experimental: Standard Care + iFuse 3-D
Multilevel Lumbar Fusion Surgery with additional placement of iFuse 3-D in a trajectory parallel to the S2AI screws
Procedure: Multilevel Lumbar Fusion surgery
Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.
Device: iFuse 3-D in Bedrock Configuration
Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed, additionally iFuse 3-D implants are placed in a trajectory parallel to the S2AI screws.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion with S2AI screw abnormality on CT scan
Time Frame: 2 years
Proportion of subjects with any of following: S2AI screw breakage, loosening or pullout OR rod breakage distal to S1 on 2-year CT scan as interpreted by an independent bone radiologist
2 years
Incidence of SI Joint pain
Time Frame: 2 years
Proportion of subjects without SI joint pain at baseline who develop new onset SI joint pain by 2 years
2 years
Change from baseline in self-reported SI joint pain at 2 years
Time Frame: 2 years
Change from baseline in self-reported SI joint pain on a 0 (no pain) -10 (worst imaginable pain) visual analog scale
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects requiring revision, removal, reoperation or supplemental fixation
Time Frame: 2 years
Proportion of subjects requiring revision, removal, reoperation or supplemental fixation related to S2AI screws or iFuse-3D
2 years
Therapeutic injection or other non-medication based intervention
Time Frame: 2 years
Proportion of subjects requiring therapeutic injection or other non-medication based intervention to treat SI joint pain
2 years
Oswestry Disability Index
Time Frame: 2 years
Change from baseline in self reported Oswestry Disability Index (ODI) score at 2 years
2 years
EuroQol Group Health Questionnaire
Time Frame: 2 years
Change from baseline in self reported EuroQol Group Health Questionnaire with Time Trade Off Utility Index (EQ-5D TTO index) score at 2 years
2 years
Scoliosis Research Society 22r Patient Questionnaire
Time Frame: 2 years
Change from baseline in self reported Scoliosis Research Society 22r Patient Questionnaire (SRS-22R) score at 2 years
2 years
Ambulatory and Work Status
Time Frame: 2 years
Change from baseline in self reported ambulatory and work status at 2 years
2 years
Opioid Medication Use
Time Frame: 2 years
Change from baseline opioid medications used, i.e., the mean daily dose during 2 weeks prior to each visit
2 years
Proportion of S2AI screw breakage
Time Frame: 2 years
Proportion of S2AI screws with any breakage over the course of the study on CT scan as interpreted by an independent bone radiologist
2 years
Proportion of S2AI screw loosening
Time Frame: 2 years
Proportion of S2AI screws with any loosening over the course of the study on CT scan as interpreted by an independent bone radiologist
2 years
iFuse-3D implant fully seated
Time Frame: 2 years
Proportion of iFuse-3D implants placed fully seated (at least 20mm) into the sacrum on 2-year CT scan as interpreted by an independent bone radiologist
2 years
iFuse-3D implant position
Time Frame: 2 years
Proportion of iFuse-3D implants with malposition (distal end outside of ilium) on 2-year CT scan as interpreted by an independent bone radiologist
2 years
Proportion of abnormal bone reactions in the pelvis
Time Frame: 2 years
Proportion of abnormal bone reactions in the pelvis at either the iFuse-3D implant or S2AI screw on 2-year CT scan as interpreted by an independent bone radiologist
2 years
Change from baseline thoracic kyphosis at 2 years
Time Frame: 2 years
Change from baseline thoracic kyphosis on 2-year CT scan as interpreted by an independent bone radiologist
2 years
Change from baseline pelvic tilt at 2 years
Time Frame: 2 years
Change from baseline pelvic tilt on 2-year CT scan as interpreted by an independent bone radiologist
2 years
Change from baseline pelvic incidence at 2 years
Time Frame: 2 years
Change from baseline pelvic incidence on 2-year CT scan as interpreted by an independent bone radiologist
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SI-BONE, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Daniel Cher, MD, SI-BONE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 300726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to share data through Yale Open Data Access. Interested researcher may submit analysis plans to Yale.

IPD Sharing Time Frame

After 2-year data are complete.

IPD Sharing Access Criteria

Interested researcher may submit analysis plans to Yale Open Data Access program

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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