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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 1-, 3-, 6-, 12-, and 24-months
Awards & highlights

Study Summary

This trial will look at the safety & effectiveness of a device to fuse the sacroiliac joint for pain relief.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in SI joint pain measured by numerical rating scale (NRS)
Secondary outcome measures
Evidence of bone binding
Improvement from baseline in SI joint (SIJ) pain
Improvement from baseline in disability
+5 more

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.

Find a Location

Who is running the clinical trial?

SI-BONE, Inc.Lead Sponsor
12 Previous Clinical Trials
1,780 Total Patients Enrolled
Robyn Capobianco, PhDStudy DirectorSI-BONE
5 Previous Clinical Trials
2,742 Total Patients Enrolled

Media Library

iFuse TORQ (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05870488 — Phase 4
Sacroiliac Joint Dysfunction Research Study Groups: Use of iFuse TORQ for SI Joint Fusion
Sacroiliac Joint Dysfunction Clinical Trial 2023: iFuse TORQ Highlights & Side Effects. Trial Name: NCT05870488 — Phase 4
iFuse TORQ (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05870488 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this therapeutic intervention received approval from the U.S. Food and Drug Administration?

"This treatment has been approved, so its safety score was a 3."

Answered by AI

How many participants are being admitted into this research project?

"Affirmative. Clinicaltrials.gov has data that suggests this research venture is currently looking for volunteers - first posted on May 23rd 2023 and last updated June 13th 2023, the experiment requires 110 participants across 4 different sites."

Answered by AI

Are there various establishments in the city that are executing this trial?

"This particular trial is presently running at 4 distinct sites, which are located in Chesterfield, Reno, Santa Monica and other cities. To reduce the necessity of having to travel far distances for this medical study, we suggest that you pick a site closest to your current location."

Answered by AI

Is recruitment open for this investigation?

"Affirmative. Reports from clinicaltrials.gov assert that this medical trial, which was first listed on May 23rd 2023, is actively recruiting participants. A total of 110 patients need to be recruited across 4 different locations."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Source Healthcare
Crimson Pain Management
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
2023. "iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05870488.
All > Spokane
~73 spots leftby May 2026
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