iFuse TORQ for Sacroiliac Joint Dysfunction

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

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Robyn Capobianco, PhD

Principal Investigator

SI-BONE

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+