SI Joint Stabilization in Long Fusion to the Pelvis (SILVIA)

Sacroiliac Joint Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sacroiliac Joint Disruption; Scoliosis Lumbar Region
• Intervention / Treatment: Procedure: Multilevel Lumbar Fusion surgery; Device: iFuse 3-D in Bedrock Configuration

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.

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Richmond, Victoria, Australia, 3121
      • Epworth Healthcare
• Germany
  • Magdeburg, Germany, 39130
    • Klinikum Magdeburg
• Italy
  • Milan
    • Legnano, Milan, Italy, 20025
      • Ospedale Civile di Legnano- ASST Ovest Milanese
• United Kingdom
  • Stanmore, United Kingdom, HA7 4LP
    • Royal National Orthopaedic Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • La Jolla, California, United States, 92037
      • University of California, San Diego
    • La Jolla, California, United States, 92037
      • Scripps Hospital
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine of USC
    • San Francisco, California, United States, 94117
      • St Mary's Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health Physician Neurosurgery Group
  • Idaho
    • Coeur d'Alene, Idaho, United States, 82815
      • Axis Spine Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Regional Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo Neurosurgery
    • New York, New York, United States, 10027
      • Hospital for Special Surgery
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Tennessee
    • Nashville, Tennessee, United States, 37209
      • Tennessee Orthopaedics Alliance
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Spine
    • Fort Worth, Texas, United States, 76104
      • North Texas Neurosurgical and Spine Center
    • Plano, Texas, United States, 75093
      • Texas Back Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • UVA Spine Center - Ortho
    • Charlottesville, Virginia, United States, 22908-0212
      • University of Virginia - Dept of Neurosurgery
    • Richmond, Virginia, United States, 23235
      • Ortho Virginia Research Institute
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: Multilevel Lumbar Fusion surgery; Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects requiring revision, removal, reoperation or supplemental fixation	Proportion of subjects requiring revision, removal, reoperation or supplemental fixation related to S2AI screws or iFuse-3D	2 years
Therapeutic injection or other non-medication based intervention	Proportion of subjects requiring therapeutic injection or other non-medication based intervention to treat SI joint pain	2 years
Oswestry Disability Index	Change from baseline in self reported Oswestry Disability Index (ODI) score at 2 years	2 years
EuroQol Group Health Questionnaire	Change from baseline in self reported EuroQol Group Health Questionnaire with Time Trade Off Utility Index (EQ-5D TTO index) score at 2 years	2 years
Scoliosis Research Society 22r Patient Questionnaire	Change from baseline in self reported Scoliosis Research Society 22r Patient Questionnaire (SRS-22R) score at 2 years	2 years
Ambulatory and Work Status	Change from baseline in self reported ambulatory and work status at 2 years	2 years
Opioid Medication Use	Change from baseline opioid medications used, i.e., the mean daily dose during 2 weeks prior to each visit	2 years
Proportion of S2AI screw breakage	Proportion of S2AI screws with any breakage over the course of the study on CT scan as interpreted by an independent bone radiologist	2 years
Proportion of S2AI screw loosening	Proportion of S2AI screws with any loosening over the course of the study on CT scan as interpreted by an independent bone radiologist	2 years
iFuse-3D implant fully seated	Proportion of iFuse-3D implants placed fully seated (at least 20mm) into the sacrum on 2-year CT scan as interpreted by an independent bone radiologist	2 years
iFuse-3D implant position	Proportion of iFuse-3D implants with malposition (distal end outside of ilium) on 2-year CT scan as interpreted by an independent bone radiologist	2 years
Proportion of abnormal bone reactions in the pelvis	Proportion of abnormal bone reactions in the pelvis at either the iFuse-3D implant or S2AI screw on 2-year CT scan as interpreted by an independent bone radiologist	2 years
Change from baseline thoracic kyphosis at 2 years	Change from baseline thoracic kyphosis on 2-year CT scan as interpreted by an independent bone radiologist	2 years
Change from baseline pelvic tilt at 2 years	Change from baseline pelvic tilt on 2-year CT scan as interpreted by an independent bone radiologist	2 years
Change from baseline pelvic incidence at 2 years	Change from baseline pelvic incidence on 2-year CT scan as interpreted by an independent bone radiologist	2 years

Collaborators and Investigators

• Sponsor: SI-BONE, Inc.
• Investigators: Study Director: Daniel Cher, MD, SI-BONE

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Sacroiliac joint pain; Adult Scoliotic Spinal Deformity; multilevel lumbar surgery; SI Joint pain
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 300726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan to share data through Yale Open Data Access. Interested researcher may submit analysis plans to Yale.
• IPD Sharing Time Frame: After 2-year data are complete.
• IPD Sharing Access Criteria: Interested researcher may submit analysis plans to Yale Open Data Access program
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No