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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04062630
Recruitment Status : Active, not recruiting
First Posted : August 20, 2019
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sacroiliac Joint Disruption Scoliosis Lumbar Region Device: iFuse 3-D in Bedrock Configuration Procedure: Multilevel Lumbar Fusion surgery Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sacroiliac Joint Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
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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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Proportion of subjects requiring revision, removal, reoperation or supplemental fixation [ Time Frame: 2 years ]
    Proportion of subjects requiring revision, removal, reoperation or supplemental fixation related to S2AI screws or iFuse-3D

  2. Therapeutic injection or other non-medication based intervention [ Time Frame: 2 years ]
    Proportion of subjects requiring therapeutic injection or other non-medication based intervention to treat SI joint pain

  3. Oswestry Disability Index [ Time Frame: 2 years ]
    Change from baseline in self reported Oswestry Disability Index (ODI) score at 2 years

  4. EuroQol Group Health Questionnaire [ Time Frame: 2 years ]
    Change from baseline in self reported EuroQol Group Health Questionnaire with Time Trade Off Utility Index (EQ-5D TTO index) score at 2 years

  5. Scoliosis Research Society 22r Patient Questionnaire [ Time Frame: 2 years ]
    Change from baseline in self reported Scoliosis Research Society 22r Patient Questionnaire (SRS-22R) score at 2 years

  6. Ambulatory and Work Status [ Time Frame: 2 years ]
    Change from baseline in self reported ambulatory and work status at 2 years

  7. Opioid Medication Use [ Time Frame: 2 years ]
    Change from baseline opioid medications used, i.e., the mean daily dose during 2 weeks prior to each visit

  8. Proportion of S2AI screw breakage [ Time Frame: 2 years ]
    Proportion of S2AI screws with any breakage over the course of the study on CT scan as interpreted by an independent bone radiologist

  9. Proportion of S2AI screw loosening [ Time Frame: 2 years ]
    Proportion of S2AI screws with any loosening over the course of the study on CT scan as interpreted by an independent bone radiologist

  10. iFuse-3D implant fully seated [ Time Frame: 2 years ]
    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

  11. iFuse-3D implant position [ Time Frame: 2 years ]
    Proportion of iFuse-3D implants with malposition (distal end outside of ilium) on 2-year CT scan as interpreted by an independent bone radiologist

  12. Proportion of abnormal bone reactions in the pelvis [ Time Frame: 2 years ]
    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

  13. Change from baseline thoracic kyphosis at 2 years [ Time Frame: 2 years ]
    Change from baseline thoracic kyphosis on 2-year CT scan as interpreted by an independent bone radiologist

  14. Change from baseline pelvic tilt at 2 years [ Time Frame: 2 years ]
    Change from baseline pelvic tilt on 2-year CT scan as interpreted by an independent bone radiologist

  15. Change from baseline pelvic incidence at 2 years [ Time Frame: 2 years ]
    Change from baseline pelvic incidence on 2-year CT scan as interpreted by an independent bone radiologist


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062630


Locations
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Sponsors and Collaborators
SI-BONE, Inc.
Investigators
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Study Director: Daniel Cher, MD SI-BONE
More Information
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Responsible Party: SI-BONE, Inc.
ClinicalTrials.gov Identifier: NCT04062630    
Other Study ID Numbers: 300726
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share data through Yale Open Data Access. Interested researcher may submit analysis plans to Yale.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After 2-year data are complete.
Access Criteria: Interested researcher may submit analysis plans to Yale Open Data Access program
URL: https://yoda.yale.edu/

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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
Keywords provided by SI-BONE, Inc.:
Adult Scoliotic Spinal Deformity
Sacroiliac joint pain
multilevel lumbar surgery
SI Joint pain
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases