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Implant

SI Joint Stabilization for Sacroiliac Joint Dysfunction (SILVIA Trial)

N/A
Waitlist Available
Research Sponsored by SI-BONE, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-75 at time of screening
Patient scheduled for multilevel (>3 levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

SILVIA Trial Summary

This trial will compare patients who underwent surgery with the iFuse 3-D implant to those who did not in order to study the effectiveness of the device.

Who is the study for?
This trial is for adults aged 21-75 who are scheduled for multilevel spinal fusion surgery and can follow the study plan. They must not have severe osteoporosis, prior sacroiliac joint surgeries, or be pregnant. Those with drug abuse issues, uncontrolled psychiatric diseases, or involved in litigation related to SI joint/back pain cannot join.Check my eligibility
What is being tested?
The study compares spine surgery outcomes with and without iFuse 3-D implants in patients needing long fusions to the pelvis. It aims to see if adding these implants improves stabilization of the sacroiliac joint during recovery.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks like infection, reaction to materials (titanium), nerve damage, blood clots, pain at implant site, and complications from anesthesia.

SILVIA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 75 years old.
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I am scheduled for a major spine surgery involving more than 3 levels and fixation to the pelvis.
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I am mentally and physically able to follow the study's requirements.

SILVIA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in self-reported SI joint pain at 2 years
Incidence of SI Joint pain
Proportion with S2AI screw abnormality on CT scan
Secondary outcome measures
Ambulatory and Work Status
Change from baseline pelvic incidence at 2 years
Change from baseline pelvic tilt at 2 years
+12 more

SILVIA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard Care + iFuse 3-DExperimental Treatment2 Interventions
Multilevel Lumbar Fusion Surgery with additional placement of iFuse 3-D in a trajectory parallel to the S2AI screws
Group II: Standard careActive Control1 Intervention
Multilevel Lumbar Fusion Surgery

Find a Location

Who is running the clinical trial?

SI-BONE, Inc.Lead Sponsor
12 Previous Clinical Trials
1,677 Total Patients Enrolled
1 Trials studying Sacroiliac Joint Dysfunction
110 Patients Enrolled for Sacroiliac Joint Dysfunction
Daniel Cher, MDStudy DirectorSI-BONE
1 Previous Clinical Trials
103 Total Patients Enrolled

Media Library

iFuse 3-D in Bedrock Configuration (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04062630 — N/A
Sacroiliac Joint Dysfunction Research Study Groups: Standard care, Standard Care + iFuse 3-D
Sacroiliac Joint Dysfunction Clinical Trial 2023: iFuse 3-D in Bedrock Configuration Highlights & Side Effects. Trial Name: NCT04062630 — N/A
iFuse 3-D in Bedrock Configuration (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04062630 — N/A
Sacroiliac Joint Dysfunction Patient Testimony for trial: Trial Name: NCT04062630 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in the experiment?

"To be considered for enrolment, the patient must have a lumbar issue and fall between 21 and 75 years of age. Approximately 213 participants are needed to complete this trial's recruitment process."

Answered by AI

Does this trial encompass participants aged 20 or above?

"In order to be considered for this medical trial, the patient must have surpassed their 21st birthday and not yet reached their 75th."

Answered by AI

Where are the various centers managing this clinical trial?

"Currently, this medical trial is enrolling patients in 24 different places, including Fort Wayne, Ann Arbor and Austin. To make the process easier for those involved we recommend that participants choose a site closest to them to limit travel requirements."

Answered by AI

What is the primary intention of this investigation?

"This two-year trial measures the primary outcome, which is the Proportion of S2AI screws with any abnormality on CT scan. Secondary outcomes include Proportion of S2AI screw loosening, Proportional requirement for revision, removal or reoperation related to SI joint pain and Therapeutic injection rate as a consequence of study treatment."

Answered by AI

Is this trial enrolling participants at the moment?

"This specific medical trial is not recruiting patients, as indicated on clinicaltrials.gov; the experiment's initial posting was May 20th 2020 and its most recent update occurred July 18th 2022. There are however 76 other trials currently enrolling candidates."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Keck School of Medicine of USC
OrthoCarolina Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I have had two back surgeries and still deal with constant pain.
PatientReceived 2+ prior treatments
~9 spots leftby Jun 2024