SI Joint Stabilization in Long Fusion to the Pelvis

Not Applicable

Completed

• Conditions: Scoliosis Lumbar Region; Sacroiliac Joint Disruption

• Registration Number: NCT04062630
• Lead Sponsor: SI-BONE, Inc.

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.

Study Timeline

• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Study Start: 2020-05-20
• Primary Completion: 2024-12-17
• Study Completion: 2025-01-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in self-reported SI joint pain at 2 years	2 years	Change from baseline in self-reported SI joint pain on a 0 (no pain) -10 (worst imaginable pain) visual analog scale
Incidence of SI Joint pain	2 years	Proportion of subjects without SI joint pain at baseline who develop new onset SI joint pain by 2 years
Proportion with S2AI screw abnormality on CT scan	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

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects requiring revision, removal, reoperation or supplemental fixation	2 years	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	2 years	Proportion of subjects requiring therapeutic injection or other non-medication based intervention to treat SI joint pain
Scoliosis Research Society 22r Patient Questionnaire	2 years	Change from baseline in self reported Scoliosis Research Society 22r Patient Questionnaire (SRS-22R) score at 2 years
Change from baseline thoracic kyphosis at 2 years	2 years	Change from baseline thoracic kyphosis on 2-year CT scan as interpreted by an independent bone radiologist
Change from baseline pelvic incidence at 2 years	2 years	Change from baseline pelvic incidence on 2-year CT scan as interpreted by an independent bone radiologist
Oswestry Disability Index	2 years	Change from baseline in self reported Oswestry Disability Index (ODI) score at 2 years
EuroQol Group Health Questionnaire	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
Ambulatory and Work Status	2 years	Change from baseline in self reported ambulatory and work status at 2 years
Opioid Medication Use	2 years	Change from baseline opioid medications used, i.e., the mean daily dose during 2 weeks prior to each visit
Proportion of S2AI screw breakage	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
Proportion of S2AI screw loosening	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
Change from baseline pelvic tilt at 2 years	2 years	Change from baseline pelvic tilt on 2-year CT scan as interpreted by an independent bone radiologist
Proportion of abnormal bone reactions in the pelvis	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
iFuse-3D implant fully seated	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
iFuse-3D implant position	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

Trial Locations

Locations (31)

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

Scroll for more (21 remaining)