CompletedNot Applicable

SI Joint Stabilization in Long Fusion to the Pelvis

United States213 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 range21 Years – 75 Years

SexALL

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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
✕. Surgeon plans to use iliac screw for pelvic fixation

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