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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04062630
Registration number
NCT04062630
Ethics application status
Date submitted
8/08/2019
Date registered
20/08/2019
Date last updated
16/04/2024
Titles & IDs
Public title
SI Joint Stabilization in Long Fusion to the Pelvis
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Scientific title
Sacroiliac Joint Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial
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Secondary ID [1]
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300726
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Universal Trial Number (UTN)
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Trial acronym
SILVIA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sacroiliac Joint Disruption
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Scoliosis Lumbar Region
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - iFuse 3-D in Bedrock Configuration
Treatment: Surgery - Multilevel Lumbar Fusion surgery
Active Comparator: Standard care - Multilevel Lumbar Fusion Surgery
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
Treatment: Devices: 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.
Treatment: Surgery: Multilevel Lumbar Fusion surgery
Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion with S2AI screw abnormality on CT scan
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Assessment method [1]
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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
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Timepoint [1]
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2 years
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Primary outcome [2]
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Incidence of SI Joint pain
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Assessment method [2]
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Proportion of subjects without SI joint pain at baseline who develop new onset SI joint pain by 2 years
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Timepoint [2]
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2 years
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Primary outcome [3]
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Change from baseline in self-reported SI joint pain at 2 years
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Assessment method [3]
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Change from baseline in self-reported SI joint pain on a 0 (no pain) -10 (worst imaginable pain) visual analog scale
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Timepoint [3]
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2 years
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Secondary outcome [1]
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Proportion of subjects requiring revision, removal, reoperation or supplemental fixation
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Assessment method [1]
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Proportion of subjects requiring revision, removal, reoperation or supplemental fixation related to S2AI screws or iFuse-3D
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Therapeutic injection or other non-medication based intervention
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Assessment method [2]
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Proportion of subjects requiring therapeutic injection or other non-medication based intervention to treat SI joint pain
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Oswestry Disability Index
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Assessment method [3]
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Change from baseline in self reported Oswestry Disability Index (ODI) score at 2 years
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Timepoint [3]
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2 years
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Secondary outcome [4]
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EuroQol Group Health Questionnaire
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Assessment method [4]
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Change from baseline in self reported EuroQol Group Health Questionnaire with Time Trade Off Utility Index (EQ-5D TTO index) score at 2 years
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Scoliosis Research Society 22r Patient Questionnaire
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Assessment method [5]
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Change from baseline in self reported Scoliosis Research Society 22r Patient Questionnaire (SRS-22R) score at 2 years
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Ambulatory and Work Status
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Assessment method [6]
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Change from baseline in self reported ambulatory and work status at 2 years
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Timepoint [6]
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2 years
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Secondary outcome [7]
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Opioid Medication Use
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Assessment method [7]
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Change from baseline opioid medications used, i.e., the mean daily dose during 2 weeks prior to each visit
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Timepoint [7]
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2 years
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Secondary outcome [8]
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Proportion of S2AI screw breakage
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Assessment method [8]
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Proportion of S2AI screws with any breakage over the course of the study on CT scan as interpreted by an independent bone radiologist
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Timepoint [8]
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2 years
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Secondary outcome [9]
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Proportion of S2AI screw loosening
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Assessment method [9]
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Proportion of S2AI screws with any loosening over the course of the study on CT scan as interpreted by an independent bone radiologist
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Timepoint [9]
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2 years
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Secondary outcome [10]
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iFuse-3D implant fully seated
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Assessment method [10]
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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
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Timepoint [10]
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2 years
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Secondary outcome [11]
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iFuse-3D implant position
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Assessment method [11]
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Proportion of iFuse-3D implants with malposition (distal end outside of ilium) on 2-year CT scan as interpreted by an independent bone radiologist
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Timepoint [11]
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2 years
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Secondary outcome [12]
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Proportion of abnormal bone reactions in the pelvis
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Assessment method [12]
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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
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Timepoint [12]
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2 years
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Secondary outcome [13]
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Change from baseline thoracic kyphosis at 2 years
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Assessment method [13]
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Change from baseline thoracic kyphosis on 2-year CT scan as interpreted by an independent bone radiologist
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Timepoint [13]
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2 years
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Secondary outcome [14]
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Change from baseline pelvic tilt at 2 years
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Assessment method [14]
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Change from baseline pelvic tilt on 2-year CT scan as interpreted by an independent bone radiologist
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Timepoint [14]
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2 years
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Secondary outcome [15]
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Change from baseline pelvic incidence at 2 years
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Assessment method [15]
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Change from baseline pelvic incidence on 2-year CT scan as interpreted by an independent bone radiologist
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Timepoint [15]
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2 years
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Eligibility
Key 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
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Minimum age
21
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/05/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
213
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Epworth HealthCare - Richmond
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Recruitment postcode(s) [1]
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3121 - Richmond
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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Arkansas
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Country [3]
0
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United States of America
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State/province [3]
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California
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Country [4]
0
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United States of America
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State/province [4]
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Colorado
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Country [5]
0
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United States of America
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State/province [5]
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Florida
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Country [6]
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United States of America
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State/province [6]
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Idaho
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Country [7]
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United States of America
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State/province [7]
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Illinois
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Country [8]
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United States of America
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State/province [8]
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Indiana
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Country [9]
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United States of America
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State/province [9]
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Michigan
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Country [10]
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United States of America
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State/province [10]
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Minnesota
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Country [11]
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United States of America
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State/province [11]
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New York
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Country [12]
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United States of America
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State/province [12]
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North Carolina
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Country [13]
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United States of America
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State/province [13]
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Ohio
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Country [14]
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United States of America
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State/province [14]
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Tennessee
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Country [15]
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United States of America
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State/province [15]
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Texas
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Country [16]
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United States of America
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State/province [16]
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Virginia
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Country [17]
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United States of America
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State/province [17]
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Washington
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Country [18]
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Germany
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State/province [18]
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Magdeburg
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Country [19]
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Italy
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State/province [19]
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Milan
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Country [20]
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United Kingdom
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State/province [20]
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Stanmore
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
SI-BONE, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04062630
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Daniel Cher, MD
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Address
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SI-BONE
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04062630
Download to PDF