iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction: a prospective, multicenter, post-market, single arm study
Clinical Trial & Research Study
Study Purpose
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iSpine Clinics and SI-Bone are partnering on the STACI study to investigate minimally invasive SI joint fusion for the treatment of chronic sacroiliac joint pain. This pain typically presents as low back and/or buttock pain which worsens with sitting, standing, or climbing the stairs. The purpose of the STACI study is to provide data on the efficacy and safety of iFuse TORQ for SI joint fusion. The iFuse TORQ implant is an FDA-cleared device for the treatment of SI joint dysfunction and participation in the STACI study is not a requirement for undergoing the procedure. If you would like to learn more about iFuse TORQ and the STACI study, please complete the survey below or schedule a visit at one of our clinics.
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction: a prospective, multicenter, post-market, single arm study
- IRB Protocol #20231562
- Sponsor: SI-Bone
- Anticipated total enrollment of 110 subjects at 15 sites
About the Study
After you and your provider determine that you are a candidate for SI joint fusion with the iFuse TORQ implant, you will be contacted by the research team at iSpine Clinics to begin enrollment. Subjects in the STACI study will be required to attend regular in-clinic follow-up visits over the course of their participation. During these visits, you will be asked to complete brief questionnaires relating to your pain and activity levels. Your participation in study will conclude 24 months after receiving the iFuse TORQ implant.
Can I Participate?
To be included in the study, you must meet these criteria (Inclusion Criteria):
- 21 years of age or older.
- Low back pain for greater than 6 months which has not responded to non-surgical care
- Previously diagnosed with SI joint dysfunction
- Baseline pain greater than 5/10
- BMI <35
You may not be eligible for the study if you have any of these criteria (Exclusion Criteria):
- Current diagnosis of cluneal neuralgia, fibromyalgia, severe osteoporosis, or chronic rheumatologic conditions
- Severe back pain due to conditions other than SI joint dysfunction
- Known allergy to titanium or titanium alloys
- Current local or systemic infection
- History of recent (<1 year) major trauma to the pelvis
- Currently participating in another interventional clinical trial
- Currently pregnant or planning pregnancy in the next 2 years
- Previous SI Joint implant, including allograft
- Currently a prisoner or ward of the state
- Currently seeking worker’s compensation, disability renumeration and/or involved in injury litigation
- Diagnosed psychiatric disease that could interfere with study participation.
If you don’t meet the above specified requirements but have sacroiliac joint dysfunction, you can still undergo the procedure outside of the clinical trial. If interested, kindly reach out to your iSpine Clinics provider or simply give us a call.