SI Joint Stabilization in Long Fusion to the Pelvis

NCT04062630 | Completed

• 1 other identifier: 300726
• Study Type: interventional
• Target: 213
• Locations: 5 countries
• Sites: 31

Brief 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.

Conditions

Sacroiliac Joint Disruption; Scoliosis Lumbar Region

Keywords

Adult Scoliotic Spinal Deformity; Sacroiliac joint pain; multilevel lumbar surgery; SI Joint pain

Outcome Measures

Primary Outcomes (3)

• Proportion with S2AI screw abnormality on CT scan

  Proportion of subjects with any of following: S2AI screw breakage, loosening or pullout OR rod breakage distal to S1 on 2-year CT scan as interpreted by an independent bone radiologist

  2 years

• Incidence of SI Joint pain

  Proportion of subjects without SI joint pain at baseline who develop new onset SI joint pain by 2 years

  2 years

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

  Change from baseline in self-reported SI joint pain on a 0 (no pain) -10 (worst imaginable pain) visual analog scale

  2 years

Secondary Outcomes (15)

• Proportion of subjects requiring revision, removal, reoperation or supplemental fixation

  2 years

• Therapeutic injection or other non-medication based intervention

  2 years

• Oswestry Disability Index

  2 years

• EuroQol Group Health Questionnaire

  2 years

• Scoliosis Research Society 22r Patient Questionnaire

  2 years

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Multilevel Lumbar Fusion Surgery

Procedure: Multilevel Lumbar Fusion surgery

Standard Care + iFuse 3-D

EXPERIMENTAL

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: Multilevel Lumbar Fusion surgery

Interventions

iFuse 3-D in Bedrock Configuration DEVICE

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.

Standard Care + iFuse 3-D

Multilevel Lumbar Fusion surgery PROCEDURE

Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.

Standard Care + iFuse 3-D; Standard care

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Any known sacral or iliac pathology
• Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
• Known metabolic bone disease
• Severe osteoporosis
• Known allergy to titanium or titanium alloys
• Use of medications known to have detrimental effects on bone quality and soft-tissue healing
• Neurologic condition that would interfere with postoperative physical therapy

Sponsors & Collaborators

• SI-BONE, Inc.: lead

Study Sites (31)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Scripps Hospital

La Jolla, California, 92037, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

St Mary's Medical Center

San Francisco, California, 94117, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Orlando Health Physician Neurosurgery Group

Orlando, Florida, 32806, United States

Location

Axis Spine Center

Coeur d'Alene, Idaho, 82815, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Parkview Regional Medical Center

Fort Wayne, Indiana, 46845, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Buffalo Neurosurgery

Buffalo, New York, 14203, United States

Location

Hospital for Special Surgery

New York, New York, 10027, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Tennessee Orthopaedics Alliance

Nashville, Tennessee, 37209, United States

Location

Austin Spine

Austin, Texas, 78705, United States

Location

North Texas Neurosurgical and Spine Center

Fort Worth, Texas, 76104, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

UVA Spine Center - Ortho

Charlottesville, Virginia, 22903, United States

Location

University of Virginia - Dept of Neurosurgery

Charlottesville, Virginia, 22908-0212, United States

Location

Ortho Virginia Research Institute

Richmond, Virginia, 23235, United States

Location

Virginia Mason

Seattle, Washington, 98101, United States

Location

Epworth HealthCare

Richmond, Victoria, 3121, Australia

Location

Klinikum Magdeburg

Magdeburg, 39130, Germany

Location

Ospedale Civile di Legnano- ASST Ovest Milanese

Legnano, Milan, 20025, Italy

Location

Royal National Orthopaedic Hospital

Stanmore, HA7 4LP, United Kingdom

Location

Related Publications (1)

• Polly DW Jr. The Sacroiliac Joint: A Current State-of-the-Art Review. JBJS Rev. 2024 Feb 5;12(2). doi: 10.2106/JBJS.RVW.23.00151. eCollection 2024 Feb 1.

  PMID: 38315777 DERIVED

Study Officials

• Daniel Cher, MD

  SI-BONE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 20, 2019
• Study Start: May 20, 2020
• Primary Completion: December 17, 2024
• Study Completion: January 15, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After 2-year data are complete.
• Access Criteria: Interested researcher may submit analysis plans to Yale Open Data Access program

Locations

GB (1); AU (1); US (27); IT (1); DE (1)