iFuse TORQ for Sacroiliac Joint Dysfunction

(STACI Trial)

Not currently recruiting at 15 trial locations

Overseen By Robyn Capobianco, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: SI-BONE, Inc.

Disqualifiers: Severe back pain, Sacroiliac pathology, Osteoporosis, Rheumatologic condition, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called iFuse TORQ for individuals with sacroiliac joint dysfunction, a condition often causing lower back or buttock pain. The goal is to determine if this implant relieves pain and enhances daily life for those whose pain persists despite other treatments. Individuals with chronic lower back or buttock pain for at least six months and a diagnosis of sacroiliac joint dysfunction may be suitable candidates. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for a broader patient population.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the iFuse TORQ treatment?

Research has shown that the iFuse TORQ implant system is generally safe for treating sacroiliac joint issues. Many studies have found that this device is both effective and safe. Early clinical trials of sacroiliac joint fusion with the iFuse TORQ implant demonstrated its safety and improved outcomes compared to no surgery.

Moreover, over 55 published articles have reviewed the safety and effectiveness of the iFuse Implant System, including the iFuse TORQ. This extensive data supports its safety for patients. As this trial is Phase 4, the treatment has already received approval for use, indicating a strong safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

iFuse TORQ is unique because it offers a minimally invasive solution for sacroiliac (SI) joint dysfunction, which traditionally requires more extensive surgical procedures. Unlike standard treatments such as open surgery or non-surgical options like physical therapy and injections, iFuse TORQ utilizes a small, implantable device designed to stabilize and fuse the SI joint with minimal disruption to surrounding tissues. Researchers are excited about this approach as it promises quicker recovery times and potentially better long-term outcomes for patients suffering from chronic SI joint pain.

What evidence suggests that iFuse TORQ is effective for sacroiliac joint dysfunction?

Research shows that the iFuse TORQ implant system, which trial participants will receive, effectively treats sacroiliac joint dysfunction. In earlier studies, patients reported a significant reduction in pain, with average pain scores decreasing from 8.7 to 0.9 over 12 months—an improvement of 7.8 points. The treatment also enhances physical function and overall quality of life compared to traditional methods. Over 55 published articles have featured the iFuse TORQ system, confirming its safety and effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Robyn Capobianco, PhD

Principal Investigator

SI-BONE

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am over 21 years old.

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

I have been diagnosed with sacroiliac joint dysfunction.

Exclusion Criteria

Currently pregnant or planning pregnancy in the next 2 years (self-reported)

My health is severely limited by my illness.

You have a known allergy to titanium or materials made with titanium.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants with SI joint dysfunction are treated with iFuse TORQ

6 months

Regular visits at baseline, 1-, 3-, and 6-months

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Follow-up visits at 12- and 24-months

What Are the Treatments Tested in This Trial?

Interventions

• iFuse TORQ

Trial Overview 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.

How Is the Trial Designed?

Group I: Use of iFuse TORQ for SI Joint Fusion Experimental Treatment 1 Intervention

Participants with SI joint dysfunction are treated with iFuse TORQ.

Who Is Running the Clinical Trial?

SI-BONE, Inc.

Lead Sponsor

Trials

14

Recruited

2,800+

Citations

1. ous.si-bone.com ous.si-bone.com/providers/clinical-evidence/data

Clinical Data on the iFuse Implant System ... Sacroiliac Joint Dysfunction: 12-Month Outcomes ... A systematic review of the clinical efficacy of sacroiliac joint stabilization in the treatment of lower back ...

2. si-bone.com si-bone.com/providers/clinical-evidence/data

Clinical Data on the iFuse Implant System More than 55 published articles have reported on the safety, effectiveness, biomechanics and economic benefits of the iFuse Implant.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11823858/

Stealth Navigation with iFuse-TORQ Implant for Sacroiliac ... Minimally invasive SI joint fusion has been shown to improve pain, physical function, and quality of life when compared to conservative management [5]. This ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23997957/

Minimally invasive sacroiliac joint fusion: one-year ... There were no reoperations at one year. Mean pain score improved from 8.7 (1.5 SD) at baseline to 0.9 (1.6) at 12 months, a 7.8-point improvement (P < .

5. ous.si-bone.com ous.si-bone.com/providers/clinical-evidence/data/cost-effectiveness-of-minimally-invasive-sacroiliac-joint-fusion

iFuse Cost-Effectiveness (Cher - CEOR 2016) Results: SIJ fusion was associated with a gain of approximately 0.74 quality-adjusted life years (QALYs) at a cost of US$13,313 per QALY gained. In multiple one ...

6. journals.lww.com journals.lww.com/spinejournal/fulltext/2025/05010/prospective_trial_of_sacroiliac_joint_fusion_using.6.aspx

Prospective Trial of Sacroiliac Joint Fusion Using... : Spine Initial clinical trials showed that SIJF using this device was safe and effective and offered better outcomes compared with nonsurgical management,8–10 with ...

7. trialx.com trialx.com/clinical-trials/listings/258697/ifuse-torq-for-the-treatment-of-sacroiliac-joint-dysfunction/

iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction Overview. STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system. Description.