CompletedNot Applicable

SI Joint Stabilization in Long Fusion to the Pelvis

United States, Australia, Germany213 participantsStarted 2020-05-20

Plain-language summary

The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.

Who can participate

Age range

21 Years – 75 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 21-75 at time of screening
. Patient scheduled for multilevel (\>3 levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
. 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

. Indication for multilevel spine fusion surgery is any of the following:
. Congenital neuromuscular disease
. Prior pelvic fixation (i.e., patient already has S2AI or iliac bolts in place, current surgery indicated to revise this hardware)
. Grade IV spondylolisthesis
. Prior sacroiliac joint fusion/fixation on either side
. Presence of spinal cord stimulator
. Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery

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

Proportion with S2AI screw abnormality on CT scan

Timeframe: 2 years

Incidence of SI Joint pain

Timeframe: 2 years

Change from baseline in self-reported SI joint pain at 2 years

Timeframe: 2 years

Trial details

NCT IDNCT04062630

SponsorSI-BONE, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-17

View on ClinicalTrials.gov More Sacroiliac Joint Disruption trials

Who can participate

Age range

21 Years – 75 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 21-75 at time of screening
. Patient scheduled for multilevel (\>3 levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
. 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

. Indication for multilevel spine fusion surgery is any of the following:
. Congenital neuromuscular disease
. Prior pelvic fixation (i.e., patient already has S2AI or iliac bolts in place, current surgery indicated to revise this hardware)
. Grade IV spondylolisthesis
. Prior sacroiliac joint fusion/fixation on either side
. Presence of spinal cord stimulator
. Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery