SI Joint Stabilization in Long Fusion to the Pelvis

SI-BONE, Inc.213 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

213

Conditions

Sacroiliac Joint Disruption Scoliosis Lumbar Region

Interventions

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

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (31)

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 2 years

Secondary Outcomes

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

Time frame: 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

Time frame: 2 years

Oswestry Disability Index

Change from baseline in self reported Oswestry Disability Index (ODI) score at 2 years

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Barrow Neurological Institute

Phoenix, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Scripps Hospital

La Jolla, California, United States

University of California, San Diego

La Jolla, California, United States

Keck School of Medicine of USC

Los Angeles, California, United States

St Mary's Medical Center

San Francisco, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Orlando Health Physician Neurosurgery Group

Orlando, Florida, United States

Axis Spine Center

Coeur d'Alene, Idaho, United States

Rush University Medical Center

Chicago, Illinois, United States

...and 21 more locations