Sacroiliac Joint DisruptionSILVIANCT04062630
SI Joint Stabilization in Long Fusion to the Pelvis
A study testing iFuse 3-D in Bedrock Configuration and Multilevel Lumbar Fusion surgery in people with Sacroiliac Joint Disruption and Scoliosis Lumbar Region, run by SI-BONE, Inc. at 31 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Sacroiliac Joint Disruption, Scoliosis Lumbar Region
- What is being tested?
- iFuse 3-D in Bedrock Configuration and Multilevel Lumbar Fusion surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 31 sitesin 5 countries
- Study dates
- 20 May 2020to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
31 sites in 5 countries.
31 sites in 5 countries
United States27 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado Denver
Aurora, Colorado, 80045
Austin Spine
Austin, Texas, 78705
University of Buffalo Neurosurgery
Buffalo, New York, 14203
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
UVA Spine Center - Ortho
Charlottesville, Virginia, 22903
University of Virginia - Dept of Neurosurgery
Charlottesville, Virginia, 22908-0212
Rush University Medical Center
Chicago, Illinois, 60612
Axis Spine Center
Coeur d'Alene, Idaho, 82815
Ohio State University
Columbus, Ohio, 43210
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845
North Texas Neurosurgical and Spine Center
Fort Worth, Texas, 76104
Scripps Hospital
La Jolla, California, 92037
University of California, San Diego
La Jolla, California, 92037
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Keck School of Medicine of USC
Los Angeles, California, 90033
University of Minnesota
Minneapolis, Minnesota, 55454
Tennessee Orthopaedics Alliance
Nashville, Tennessee, 37209
Hospital for Special Surgery
New York, New York, 10027
Orlando Health Physician Neurosurgery Group
Orlando, Florida, 32806
Barrow Neurological Institute
Phoenix, Arizona, 85013
Texas Back Institute
Plano, Texas, 75093
Ortho Virginia Research Institute
Richmond, Virginia, 23235
Mayo Clinic
Rochester, Minnesota, 55905
William Beaumont Hospital
Royal Oak, Michigan, 48073
St Mary's Medical Center
San Francisco, California, 94117
Virginia Mason
Seattle, Washington, 98101
Italy1 site
Ospedale Civile di Legnano- ASST Ovest Milanese
Legnano, Milan, 20025
United Kingdom1 site
Royal National Orthopaedic Hospital
Stanmore, HA7 4LP
About this study
Official title: 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.
Read the 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.
- Being tested
- iFuse 3-D in Bedrock Configuration, Multilevel Lumbar Fusion surgery
- Keywords
- Adult Scoliotic Spinal Deformity, Sacroiliac joint pain, multilevel lumbar surgery, SI Joint pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFuse 3-D in Bedrock ConfigurationDevice
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.
Multilevel Lumbar Fusion surgeryProcedure or surgery
Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Multilevel Lumbar Fusion Surgery Receives: 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 Receives: Device: iFuse 3-D in Bedrock Configuration; Procedure: Multilevel Lumbar Fusion surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 2 years
Secondary outcomes (15)
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
Measured: 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
Measured: 2 years
Oswestry Disability Index
Change from baseline in self reported Oswestry Disability Index (ODI) score at 2 years
Measured: 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
Measured: 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
Measured: 2 years
Ambulatory and Work Status
Change from baseline in self reported ambulatory and work status at 2 years
Measured: 2 years
Opioid Medication Use
Change from baseline opioid medications used, i.e., the mean daily dose during 2 weeks prior to each visit
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start20 May 2020
- Primary completion17 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac Joint DisruptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- SI-BONE, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Cher, MD, Study director, SI-BONE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062630
- Sponsor's protocol ID
- 300726
- Acronym
- SILVIA
- Status last verified
- Feb 2025
- First submitted
- 8 Aug 2019
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share data through Yale Open Data Access. Interested researcher may submit analysis plans to Yale.
Publications
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.
PubMed 38315777
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacroiliac Joint Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04062630
- Acronym / sponsor ID
- SILVIA / 300726
- Keywords
- Adult Scoliotic Spinal Deformity, Sacroiliac joint pain, multilevel lumbar surgery, SI Joint pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- SI-BONE, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2020 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Procedure: Multilevel Lumbar Fusion surgeryMultilevel Lumbar Fusion Surgery |
| Standard Care + iFuse 3-D | Experimental | Device: iFuse 3-D in Bedrock Configuration, Procedure: Multilevel Lumbar Fusion surgeryMultilevel Lumbar Fusion Surgery with additional placement of iFuse 3-D in a trajectory parallel to the S2AI screws |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- Indication for multilevel spine fusion surgery is any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iFuse 3-D in Bedrock ConfigurationProcedure 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. | Device | Standard Care + iFuse 3-D |
| Multilevel Lumbar Fusion surgeryProcedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed. | Procedure or surgery | Standard Care + iFuse 3-D, Standard care |
Primary outcome
Proportion with S2AI screw abnormality on CT scan
Time frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
Change from baseline in self-reported SI joint pain on a 0 (no pain) -10 (worst imaginable pain) visual analog scale
15 secondary outcomes
Proportion of subjects requiring revision, removal, reoperation or supplemental fixation
Time frame: 2 years
Therapeutic injection or other non-medication based intervention
Time frame: 2 years
Oswestry Disability Index
Time frame: 2 years
EuroQol Group Health Questionnaire
Time frame: 2 years
Scoliosis Research Society 22r Patient Questionnaire
Time frame: 2 years
Ambulatory and Work Status
Time frame: 2 years
Opioid Medication Use
Time frame: 2 years
Proportion of S2AI screw breakage
Time frame: 2 years
Proportion of S2AI screw loosening
Time frame: 2 years
iFuse-3D implant fully seated
Time frame: 2 years
iFuse-3D implant position
Time frame: 2 years
Proportion of abnormal bone reactions in the pelvis
Time frame: 2 years
Change from baseline thoracic kyphosis at 2 years
Time frame: 2 years
Change from baseline pelvic tilt at 2 years
Time frame: 2 years
Change from baseline pelvic incidence at 2 years
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Derived from this study: PubMed 38315777Polly 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.
- Individual participant dataSharing planned: Yes. Plan to share data through Yale Open Data Access. Interested researcher may submit analysis plans to Yale.
Related trials for Sacroiliac Joint Disruption
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Enrolling by invitationObservational study
Sacroiliac Joint Fusion Intervention For Mobility, Pain Relief, and Lasting Improvement in Functional Recovery "SIMPLIFY"
Degenerative Sacroiliitis, Sacroiliac Disorder
Not yet recruitingObservational study
Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes
Sacro Iliac Joint Pain, Sacro-iliac Joints
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Cher, MD study director
SI-BONE
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iFuse 3-D in Bedrock Configuration and Multilevel Lumbar Fusion surgery in people with Sacroiliac Joint Disruption and Scoliosis Lumbar Region, run by SI-BONE, Inc. at 31 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Australia, Germany, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion with S2AI screw abnormality on CT scan (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04062630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.