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Completed

NCT Number: NCT04062630

SI Joint Stabilization in Long Fusion to the Pelvis

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.

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Key information

Conditions

Sacroiliac Joint Disruption Scoliosis Lumbar Region

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Epworth HealthCare, Richmond, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Multilevel Lumbar Fusion surgery

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

SI-BONE, Inc.

Industry

Registry information

Official study title

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

Acronym: SILVIA

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Aug 20, 2019
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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