What side effects are associated with this type of intervention?

Common treatments for Sacroiliac Joint Dysfunction, such as SIJ fusion using implants like the iFuse 3-D, can have side effects including increased pain, transient lower limb numbness, paraesthesias, and superficial burns. Non-surgical treatments, such as periarticular steroid injections, may cause temporary pain relief but have limited long-term efficacy. Radiofrequency denervation, another non-surgical option, can lead to modest pain improvement but may also result in adverse events like increased pain and transient numbness. Overall, while these treatments can provide relief, they are not without risks and potential complications.

What prior FDA approvals exist?

The FDA has approved several treatments for Sacroiliac Joint Dysfunction, including minimally invasive surgical options like the iFuse Implant System®. This system uses triangular titanium implants to provide structural support and stability, particularly in lumbar fusion surgeries. These implants are designed to promote fusion and reduce pain by stabilizing the sacroiliac joint. Other treatments may include sacroiliac joint injections and radiofrequency denervation, although these are less focused on structural support compared to the iFuse implants.

What other types of research exist?

Promising alternatives to iFuse 3-D implants for sacroiliac joint dysfunction include 3D-printed triangular titanium implants (TTI), which have demonstrated strong evidence of safety and effectiveness. Cylindrical threaded implants are another option, though more research is needed to fully understand their efficacy.

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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

Must not have

Any known sacral or iliac pathology

Prior pelvic fixation (i.e., patient already has S2AI or iliac bolts in place, current surgery indicated to revise this hardware)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding iFuse 3-D implants to a common back surgery can help reduce pain and prevent complications. It targets patients undergoing complex back surgery and aims to see if the implants provide extra support.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a known condition affecting my sacrum or iliac bones.

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I have had surgery to fix my pelvis before and need another one to adjust the hardware.

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I am recommended to have surgery to fuse multiple levels of my spine.

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I have a severe spinal condition where one of my vertebrae has slipped over another.

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I have had surgery to fuse my sacroiliac joint.

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My body is not suitable for the iFuse Implant treatment.

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I have a diagnosed bone metabolism disorder.

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I have an infection that could make surgery risky.

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I have a neurological condition that could affect my ability to do physical therapy after surgery.

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I have severe hip pain that might affect my recovery from complex spine surgery.

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My surgeon plans to use an iliac screw for my pelvic surgery.

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I have severe osteoporosis.

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I have been diagnosed with fibromyalgia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Ambulatory and Work Status

Change from baseline pelvic incidence at 2 years

Change from baseline pelvic tilt at 2 years

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Sacroiliac Joint (SIJ) Dysfunction include structural interventions like the iFuse 3-D implants, which provide stability and support by fusing the joint, thereby reducing abnormal motion and alleviating pain. Manual therapy and specific exercises aim to improve joint function and muscle strength, enhancing stability and reducing discomfort. Injections, such as periarticular steroid injections, target inflammation and pain directly within the joint. These treatments are crucial for SIJ dysfunction patients as they address both the mechanical instability and the inflammatory components of the condition, leading to improved pain management and quality of life.

The Efficiency of Manual Therapy and Sacroiliac and Lumbar Exercises in Patients with Sacroiliac Joint Dysfunction Syndrome.Determination of the Prevalence From Clinical Diagnosis of Sacroiliac Joint Dysfunction in Patients With Lumbar Disc Hernia and an Evaluation of the Effect of This Combination on Pain and Quality of Life.Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction.