SI Joint Stabilization in Long Fusion to the Pelvis

Purpose

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.

Conditions

  • Sacroiliac Joint Disruption
  • Scoliosis Lumbar Region

Eligibility

Eligible Ages
Between 21 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age 21-75 at time of screening 2. Patient scheduled for multilevel (>3 levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws 3. Patient has signed study-specific informed consent form 4. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion Criteria

  1. Indication for multilevel spine fusion surgery is any of the following: 1. Congenital neuromuscular disease 2. Prior pelvic fixation (i.e., patient already has S2AI or iliac bolts in place, current surgery indicated to revise this hardware) 3. Grade IV spondylolisthesis 2. Prior sacroiliac joint fusion/fixation on either side 3. Presence of spinal cord stimulator 4. Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery 5. Surgeon plans to use iliac screw for pelvic fixation 6. Any known sacral or iliac pathology 7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible 8. Known metabolic bone disease 9. Severe osteoporosis 10. Known allergy to titanium or titanium alloys 11. Use of medications known to have detrimental effects on bone quality and soft-tissue healing 12. Neurologic condition that would interfere with postoperative physical therapy 13. Current local or systemic infection that raises the risk of surgery 14. Patient currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the SI joint or low back pain. 15. Currently pregnant or planning pregnancy in the next 2 years 16. Prisoner or a ward of the state. 17. Known or suspected drug or alcohol abuse 18. Uncontrolled psychiatric disease that could interfere with study participation 19. Fibromyalgia

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard care
Multilevel Lumbar Fusion Surgery
  • Procedure: Multilevel Lumbar Fusion surgery
    Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.
Experimental
Standard Care + iFuse 3-D
Multilevel Lumbar Fusion Surgery with additional placement of iFuse 3-D in a trajectory parallel to the S2AI screws
  • Device: iFuse 3-D in Bedrock Configuration
    Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed, additionally iFuse 3-D implants are placed in a trajectory parallel to the S2AI screws.
  • Procedure: Multilevel Lumbar Fusion surgery
    Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.

Recruiting Locations

Barrow Neurological Institute
Phoenix, Arizona 85013

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Noojan Kazemi, MD
njkazemi@uams.edu

Scripps Hospital
La Jolla, California 92037
Contact:
Gregory Mundis, MD
Mundis.Gregory@scrippshealth.org

University of California, San Diego
La Jolla, California 92037
Contact:
Vinko Zlomislic, MD
vzlomislic@ucsd.edu

Keck School of Medicine of USC
Los Angeles, California 90033
Contact:
Raymond Hah
ray.hah@med.usc.edu

St Mary's Medical Center
San Francisco, California 94117
Contact:
Jesse Day
Jesse.Day2@DignityHealth.org

University of Colorado Denver
Aurora, Colorado 80045
Contact:
Christopher Kleck
christopher.kleck@cuanschutz.edu

Orlando Health Physician Neurosurgery Group
Orlando, Florida 32806
Contact:
Virgilio Matheus, MD
Virgilio.Matheus@orlandohealth.com

Axis Spine Center
Coeur d'Alene, Idaho 82815
Contact:
Shelly Reed
s.reed@axisspinecenter.com

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Christopher DeWald, MD
Christopher.DeWald@rushortho.com

Advocate Christ Medical Center
Oak Lawn, Illinois 60453
Contact:
Richard Lim, MD
richard.lim@advocathealth.com

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Paul Park, MD
ppark@med.umich.edu

William Beaumont Hospital
Royal Oak, Michigan 48073
Contact:
Jad Khalil, MD
Jad.Khalil@beaumont.org

University of Minnesota
Minneapolis, Minnesota 55454
Contact:
Christopher Martin, MD
mart1865@umn.edu

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Benjamin Elder, M.D., PhD
elder.benjamin@mayo.edu

NYU Langone Orthopedic Hospital
New York, New York 10003
Contact:
Themistocles Protopsaltis, MD
Themistocles.Protopsaltis@nyulangone.org

Hospital for Special Surgery
New York, New York 10027
Contact:
Han Jo Kim, MD
kimh@hss.edu

OrthoCarolina Research Institute
Charlotte, North Carolina 28207
Contact:
Todd M Chapman, MD
Matt.Chapman@orthocarolina.com

Ohio State University
Columbus, Ohio 43210
Contact:
Safdar N Khan, MD
safdar.khan@osumc.edu

Tennessee Orthopaedics Alliance
Nashville, Tennessee 37209
Contact:
Ryan Snowden
snowdenrd@toa.com

North Texas Neurosurgical and Spine Center
Fort Worth, Texas 76104
Contact:
Gregory Smith, DO
GregorySmith@texashealth.org

Texas Back Institute
Plano, Texas 75093
Contact:
Rajesh Arakal, MD
rarakal@texasback.com

University of Virginia - Dept of Neurosurgery
Charlottesville, Virginia 22908-0212
Contact:
Avery Buchholz
ALB8JP@hscmail.mcc.virginia.edu

Ortho Virginia Research Institute
Richmond, Virginia 23235
Contact:
Erin Brown
Erin.Brown@orthovirginia.com

Virginia Mason
Seattle, Washington 98101
Contact:
Jean-Christophe Leveque, MD
Jean-Christophe.Leveque@virginiamason.org

More Details

NCT ID
NCT04062630
Status
Recruiting
Sponsor
SI-BONE, Inc.

Study Contact

Daniel Cher, MD
408.207.0700
dcher@si-bone.com

Detailed Description

This is a multicenter randomized controlled, postmarket clinical study to determine the differences between subjects undergoing standard MLF surgery with S2AI fixation in the pelvis vs the additional placement of iFuse 3-D in the bedrock configuration during MLF surgery. Subjects will be monitored for sacroiliac (SI) joint pain and at two years post surgery a CT scan will be taken to assess S2AI screw loosening or any other findings.