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SI Joint Stabilization for Sacroiliac Joint Dysfunction (SILVIA Trial)
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.
SILVIA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSILVIA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SILVIA Trial Design
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Who is running the clinical trial?
Media Library
- I have a known condition affecting my sacrum or iliac bones.I am not taking medications that harm bone or tissue healing.I have had surgery to fix my pelvis before and need another one to adjust the hardware.I am between 21 and 75 years old.I am scheduled for a major spine surgery involving more than 3 levels and fixation to the pelvis.I am recommended to have surgery to fuse multiple levels of my spine.I have a severe spinal condition where one of my vertebrae has slipped over another.I have had surgery to fuse my sacroiliac joint.You are allergic to titanium or materials made with titanium.You were born with a condition affecting your muscles and nerves.My body is not suitable for the iFuse Implant treatment.You have a known problem with drugs or alcohol.I have a diagnosed bone metabolism disorder.I am mentally and physically able to follow the study's requirements.I have an infection that could make surgery risky.I have a neurological condition that could affect my ability to do physical therapy after surgery.I have severe hip pain that might affect my recovery from complex spine surgery.My surgeon plans to use an iliac screw for my pelvic surgery.I have severe osteoporosis.I have been diagnosed with fibromyalgia.You have a spinal cord stimulator implant.
- Group 1: Standard care
- Group 2: Standard Care + iFuse 3-D
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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