CompletedNot Applicable

iFuse Implant System® Minimally Invasive Arthrodesis

Belgium, Germany, Italy103 participantsStarted 2013-06

Plain-language summary

The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative management of the SI joint

Who can participate

Age range

21 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 21-70 at time of screening
. Patient has lower back pain for \>6 months or \>18 months for pregnancy induced lower back pain
. Diagnosis of the SI joint as the primary lower back pain generator based on ALL of the following: a. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and b. Patient has at least 3 of 5 physical examination maneuvers specific for SI joint pain, and c. Patient has improvement in lower back pain NRS of at least 50% of the pre injection NRS score after fluoroscopic controlled injection of local anesthetic into affected SI joint(s) (including previous documented test \<6 months ago)
. Baseline Oswestry Disability Index (ODI) score of at least 30%
. Baseline lower back pain score of at least 50 on 0-100 point VAS
. Patient has signed study-specific informed consent form
. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion criteria

. Severe lower back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The change in lower back pain as rated by the study subject using a 0-100 visual analog scale (VAS) at 6 months after initiation of treatment

Timeframe: 6 months

Trial details

NCT IDNCT01741025

SponsorSI-BONE, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12-15

View on ClinicalTrials.gov More Sacroiliac Joint Pain trials