Back to resultsSI Joint Stabilization in Long Fusion to the Pelvis (SILVIA)
Primary Purpose
Sacroiliac Joint Disruption, Scoliosis Lumbar Region
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
iFuse 3-D in Bedrock Configuration
Multilevel Lumbar Fusion surgery
Sponsored by
About this trial
This is an interventional treatment trial for Sacroiliac Joint Disruption focused on measuring Adult Scoliotic Spinal Deformity, Sacroiliac joint pain, multilevel lumbar surgery, SI Joint pain
Eligibility Criteria
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
- 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
- Current local or systemic infection that raises the risk of surgery
- 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.
- Currently pregnant or planning pregnancy in the next 2 years
- Prisoner or a ward of the state.
- Known or suspected drug or alcohol abuse
- Uncontrolled psychiatric disease that could interfere with study participation
- Fibromyalgia
Sites / Locations
- Barrow Neurological Institute
- University of Arkansas for Medical Sciences
- Scripps Hospital
- University of California, San Diego
- Keck School of Medicine of USC
- St Mary's Medical Center
- University of Colorado Denver
- Orlando Health Physician Neurosurgery Group
- Axis Spine Center
- Rush University Medical Center
- Parkview Regional Medical Center
- University of Michigan
- William Beaumont Hospital
- University of Minnesota
- Mayo Clinic
- University of Buffalo Neurosurgery
- Hospital for Special Surgery
- OrthoCarolina Research Institute
- Ohio State University
- Tennessee Orthopaedics Alliance
- Austin Spine
- North Texas Neurosurgical and Spine Center
- Texas Back Institute
- UVA Spine Center - Ortho
- University of Virginia - Dept of Neurosurgery
- Ortho Virginia Research Institute
- Virginia Mason
- Epworth HealthCare
- Klinikum Magdeburg
- Ospedale Civile di Legnano- ASST Ovest Milanese
- Royal National Orthopaedic Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard care
Standard Care + iFuse 3-D
Arm Description
Multilevel Lumbar Fusion Surgery
Multilevel Lumbar Fusion Surgery with additional placement of iFuse 3-D in a trajectory parallel to the S2AI screws
Outcomes
Primary Outcome Measures
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
Incidence of SI Joint pain
Proportion of subjects without SI joint pain at baseline who develop new onset SI joint pain by 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
Secondary Outcome Measures
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
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
Oswestry Disability Index
Change from baseline in self reported Oswestry Disability Index (ODI) score at 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
Scoliosis Research Society 22r Patient Questionnaire
Change from baseline in self reported Scoliosis Research Society 22r Patient Questionnaire (SRS-22R) score at 2 years
Ambulatory and Work Status
Change from baseline in self reported ambulatory and work status at 2 years
Opioid Medication Use
Change from baseline opioid medications used, i.e., the mean daily dose during 2 weeks prior to each visit
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
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
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04062630
Brief Title
SI Joint Stabilization in Long Fusion to the Pelvis
Acronym
SILVIA
Official Title
Sacroiliac Joint Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SI-BONE, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Disruption, Scoliosis Lumbar Region
Keywords
Adult Scoliotic Spinal Deformity, Sacroiliac joint pain, multilevel lumbar surgery, SI Joint pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Multilevel Lumbar Fusion Surgery
Arm Title
Standard Care + iFuse 3-D
Arm Type
Experimental
Arm Description
Multilevel Lumbar Fusion Surgery with additional placement of iFuse 3-D in a trajectory parallel to the S2AI screws
Intervention Type
Device
Intervention Name(s)
iFuse 3-D in Bedrock Configuration
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Multilevel Lumbar Fusion surgery
Intervention Description
Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.
Primary Outcome Measure Information:
Title
Proportion with S2AI screw abnormality on CT scan
Description
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
Time Frame
2 years
Title
Incidence of SI Joint pain
Description
Proportion of subjects without SI joint pain at baseline who develop new onset SI joint pain by 2 years
Time Frame
2 years
Title
Change from baseline in self-reported SI joint pain at 2 years
Description
Change from baseline in self-reported SI joint pain on a 0 (no pain) -10 (worst imaginable pain) visual analog scale
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Proportion of subjects requiring revision, removal, reoperation or supplemental fixation
Description
Proportion of subjects requiring revision, removal, reoperation or supplemental fixation related to S2AI screws or iFuse-3D
Time Frame
2 years
Title
Therapeutic injection or other non-medication based intervention
Description
Proportion of subjects requiring therapeutic injection or other non-medication based intervention to treat SI joint pain
Time Frame
2 years
Title
Oswestry Disability Index
Description
Change from baseline in self reported Oswestry Disability Index (ODI) score at 2 years
Time Frame
2 years
Title
EuroQol Group Health Questionnaire
Description
Change from baseline in self reported EuroQol Group Health Questionnaire with Time Trade Off Utility Index (EQ-5D TTO index) score at 2 years
Time Frame
2 years
Title
Scoliosis Research Society 22r Patient Questionnaire
Description
Change from baseline in self reported Scoliosis Research Society 22r Patient Questionnaire (SRS-22R) score at 2 years
Time Frame
2 years
Title
Ambulatory and Work Status
Description
Change from baseline in self reported ambulatory and work status at 2 years
Time Frame
2 years
Title
Opioid Medication Use
Description
Change from baseline opioid medications used, i.e., the mean daily dose during 2 weeks prior to each visit
Time Frame
2 years
Title
Proportion of S2AI screw breakage
Description
Proportion of S2AI screws with any breakage over the course of the study on CT scan as interpreted by an independent bone radiologist
Time Frame
2 years
Title
Proportion of S2AI screw loosening
Description
Proportion of S2AI screws with any loosening over the course of the study on CT scan as interpreted by an independent bone radiologist
Time Frame
2 years
Title
iFuse-3D implant fully seated
Description
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
Time Frame
2 years
Title
iFuse-3D implant position
Description
Proportion of iFuse-3D implants with malposition (distal end outside of ilium) on 2-year CT scan as interpreted by an independent bone radiologist
Time Frame
2 years
Title
Proportion of abnormal bone reactions in the pelvis
Description
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
Time Frame
2 years
Title
Change from baseline thoracic kyphosis at 2 years
Description
Change from baseline thoracic kyphosis on 2-year CT scan as interpreted by an independent bone radiologist
Time Frame
2 years
Title
Change from baseline pelvic tilt at 2 years
Description
Change from baseline pelvic tilt on 2-year CT scan as interpreted by an independent bone radiologist
Time Frame
2 years
Title
Change from baseline pelvic incidence at 2 years
Description
Change from baseline pelvic incidence on 2-year CT scan as interpreted by an independent bone radiologist
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Current local or systemic infection that raises the risk of surgery
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.
Currently pregnant or planning pregnancy in the next 2 years
Prisoner or a ward of the state.
Known or suspected drug or alcohol abuse
Uncontrolled psychiatric disease that could interfere with study participation
Fibromyalgia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Cher, MD
Organizational Affiliation
SI-BONE
Official's Role
Study Director
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Scripps Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
St Mary's Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Orlando Health Physician Neurosurgery Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Axis Spine Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
82815
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Parkview Regional Medical Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Buffalo Neurosurgery
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
OrthoCarolina Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Tennessee Orthopaedics Alliance
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Austin Spine
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
North Texas Neurosurgical and Spine Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
UVA Spine Center - Ortho
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
University of Virginia - Dept of Neurosurgery
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-0212
Country
United States
Facility Name
Ortho Virginia Research Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Virginia Mason
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Epworth HealthCare
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Klinikum Magdeburg
City
Magdeburg
ZIP/Postal Code
39130
Country
Germany
Facility Name
Ospedale Civile di Legnano- ASST Ovest Milanese
City
Legnano
State/Province
Milan
ZIP/Postal Code
20025
Country
Italy
Facility Name
Royal National Orthopaedic Hospital
City
Stanmore
ZIP/Postal Code
HA7 4LP
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://yoda.yale.edu/
Learn more about this trial
SI Joint Stabilization in Long Fusion to the Pelvis
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