What side effects are associated with this type of intervention?

Common treatments for Sacroiliac Joint Dysfunction, such as the iFuse TORQ implant system, involve surgical fusion of the joint to promote bone growth and stability. Known side effects include surgical risks like infection, bleeding, nerve damage, and anesthesia reactions. Postoperative complications can include pain at the implant site, limited mobility, hardware failure, and the need for revision surgery. Recovery often involves discomfort and necessitates physical therapy.

What prior FDA approvals exist?

The FDA has approved several devices for the treatment of Sacroiliac Joint Dysfunction that focus on stabilizing the joint and promoting bone fusion. One notable example is the iFuse Implant System, which is designed to provide immediate stabilization and long-term fusion of the sacroiliac joint. This system uses triangular titanium implants to achieve joint stability and promote bone growth. Other similar devices include the Rialto SI Fusion System and the SImmetry Sacroiliac Joint Fusion System, both of which aim to stabilize the joint and encourage bone fusion through minimally invasive surgical techniques.

What other types of research exist?

Promising novel alternatives to the iFuse TORQ implant system for Sacroiliac Joint Dysfunction patients include: 1) Rialto SI Fusion System, which uses a hollow modular implant to promote bone growth and fusion. 2) SImmetry Sacroiliac Joint Fusion System, which employs decortication and bone grafting to enhance fusion. 3) CornerLoc SI Joint Stabilization System, which uses a triangular implant designed to provide immediate stability and long-term fusion. These alternatives are minimally invasive and have shown positive outcomes in recent clinical trials.

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Implant

iFuse TORQ for Sacroiliac Joint Dysfunction

Phase 4

Recruiting

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 at time of screening

Baseline SIJ pain score of at least 5 on 0-10 numerical rating scale

Must not have

ASA score 4 or 5

Current diagnosis of fibromyalgia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 1-, 3-, 6-, 12-, and 24-months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing a new device called iFuse TORQ that helps join bones in the lower back. It aims to help patients with lower back pain or instability by stabilizing and fusing their sacroiliac joint. The iFuse Implant System® has been used in minimally invasive sacroiliac joint fusion to relieve pain and improve quality of life in patients with sacroiliac joint degeneration or disruption.

Who is the study for?

This trial is for adults over 21 with sacroiliac joint dysfunction, experiencing lower back or buttock pain for at least 6 months that hasn't improved with non-surgical care. Participants must have a BMI under 35 and significant disability and pain as measured by specific scales. Exclusions include severe other back issues, certain systemic diseases, allergies to titanium, current infections, substance abuse, pregnancy plans within two years, involvement in litigation related to disability or workers' compensation claims.

What is being tested?

The STACI study is testing the iFuse TORQ implant system's effectiveness in treating sacroiliac joint dysfunction. This prospective multicenter study will evaluate how well this new device can alleviate pain and improve function compared to existing treatments.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical surgical risks such as infection risk increase due to surgery, allergic reactions to materials (titanium), nerve damage around the implant site leading to numbness or weakness, and possible increased pain during recovery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 21 years old.

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My baseline pain in the sacroiliac joint is at least a 5 out of 10.

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I have been diagnosed with sacroiliac joint dysfunction.

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I have had lower back or buttock pain for over 6 months that hasn't improved with non-surgical treatments.

Exclusion Criteria

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

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My health is severely limited by my illness.

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I have been diagnosed with fibromyalgia.

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I have severe osteoporosis or a history of fractures due to it.

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I do not have a psychiatric condition that could affect my participation.

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My body can safely accommodate the medical device.

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I have an infection that could make surgery risky.

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I have severe back pain not caused by cancer.

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I do not have conditions like ankylosing spondylitis affecting my sacroiliac joint.

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I have had a major injury to my pelvis in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 1-, 3-, 6-, 12-, and 24-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 1-, 3-, 6-, 12-, and 24-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 1-, 3-, 6-, 12-, and 24-months 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 in SI joint pain measured by numerical rating scale (NRS)

Secondary study objectives

Evidence of bone binding

Improvement from baseline in SI joint (SIJ) pain

Improvement from baseline in disability

+2 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Use of iFuse TORQ for SI Joint FusionExperimental Treatment1 Intervention

Participants with SI joint dysfunction are treated with iFuse TORQ.

0 / 13Eligibility 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 Dysfunction (SIJD) aim to stabilize the joint and reduce pain. The iFuse TORQ implant system, for example, promotes bone growth and fusion, which helps to stabilize the sacroiliac joint by creating a solid bony bridge across the joint. This stabilization is crucial for reducing the abnormal motion that causes pain. Other interventional therapies, such as steroid injections and radiofrequency ablation, target pain relief by reducing inflammation or disrupting nerve signals. These treatments are important for SIJD patients as they address both the mechanical instability and the pain, improving overall function and quality of life.