SI Joint Stabilization in Long Fusion to the Pelvis

Sacroiliac Joint Disruption Clinical Trial

— SILVIA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04062630
• Other study ID #: 300726
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: SI-BONE, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 213
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sacroiliac Joint Disruption
• Scoliosis
• Scoliosis Lumbar Region

Intervention

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.

Locations

Country	Name	City	State
Australia	Epworth HealthCare	Richmond	Victoria
Germany	Klinikum Magdeburg	Magdeburg
Italy	Ospedale Civile di Legnano- ASST Ovest Milanese	Legnano	Milan
United Kingdom	Royal National Orthopaedic Hospital	Stanmore
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado Denver	Aurora	Colorado
United States	Austin Spine	Austin	Texas
United States	University of Buffalo Neurosurgery	Buffalo	New York
United States	OrthoCarolina Research Institute	Charlotte	North Carolina
United States	University of Virginia - Dept of Neurosurgery	Charlottesville	Virginia
United States	UVA Spine Center - Ortho	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	Axis Spine Center	Coeur d'Alene	Idaho
United States	Ohio State University	Columbus	Ohio
United States	Parkview Regional Medical Center	Fort Wayne	Indiana
United States	North Texas Neurosurgical and Spine Center	Fort Worth	Texas
United States	Scripps Hospital	La Jolla	California
United States	University of California, San Diego	La Jolla	California
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Keck School of Medicine of USC	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Tennessee Orthopaedics Alliance	Nashville	Tennessee
United States	Hospital for Special Surgery	New York	New York
United States	Orlando Health Physician Neurosurgery Group	Orlando	Florida
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Texas Back Institute	Plano	Texas
United States	Ortho Virginia Research Institute	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	St Mary's Medical Center	San Francisco	California
United States	Virginia Mason	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
SI-BONE, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Primary	Incidence of SI Joint pain	Proportion of subjects without SI joint pain at baseline who develop new onset SI joint pain by 2 years	2 years
Primary	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	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	Oswestry Disability Index	Change from baseline in self reported Oswestry Disability Index (ODI) score at 2 years	2 years
Secondary	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	2 years
Secondary	Scoliosis Research Society 22r Patient Questionnaire	Change from baseline in self reported Scoliosis Research Society 22r Patient Questionnaire (SRS-22R) score at 2 years	2 years
Secondary	Ambulatory and Work Status	Change from baseline in self reported ambulatory and work status at 2 years	2 years
Secondary	Opioid Medication Use	Change from baseline opioid medications used, i.e., the mean daily dose during 2 weeks prior to each visit	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years