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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04062630




Registration number
NCT04062630
Ethics application status
Date submitted
8/08/2019
Date registered
20/08/2019

Titles & IDs
Public title
SI Joint Stabilization in Long Fusion to the Pelvis
Scientific title
Sacroiliac Joint Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial
Secondary ID [1] 0 0
300726
Universal Trial Number (UTN)
Trial acronym
SILVIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sacroiliac Joint Disruption 0 0
Scoliosis Lumbar Region 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion with S2AI screw abnormality on CT scan
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
Incidence of SI Joint pain
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
Change from baseline in self-reported SI joint pain at 2 years
Timepoint [3] 0 0
2 years
Secondary outcome [1] 0 0
Proportion of subjects requiring revision, removal, reoperation or supplemental fixation
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Therapeutic injection or other non-medication based intervention
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Oswestry Disability Index
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
EuroQol Group Health Questionnaire
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Scoliosis Research Society 22r Patient Questionnaire
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Ambulatory and Work Status
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Opioid Medication Use
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
Proportion of S2AI screw breakage
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Proportion of S2AI screw loosening
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
iFuse-3D implant fully seated
Timepoint [10] 0 0
2 years
Secondary outcome [11] 0 0
iFuse-3D implant position
Timepoint [11] 0 0
2 years
Secondary outcome [12] 0 0
Proportion of abnormal bone reactions in the pelvis
Timepoint [12] 0 0
2 years
Secondary outcome [13] 0 0
Change from baseline thoracic kyphosis at 2 years
Timepoint [13] 0 0
2 years
Secondary outcome [14] 0 0
Change from baseline pelvic tilt at 2 years
Timepoint [14] 0 0
2 years
Secondary outcome [15] 0 0
Change from baseline pelvic incidence at 2 years
Timepoint [15] 0 0
2 years

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
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
213
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Epworth HealthCare - Richmond
Recruitment postcode(s) [1] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Germany
State/province [18] 0 0
Magdeburg
Country [19] 0 0
Italy
State/province [19] 0 0
Milan
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Stanmore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
SI-BONE, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Cher, MD
Address 0 0
SI-BONE
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Plan to share data through Yale Open Data Access. Interested researcher may submit analysis plans to Yale.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
After 2-year data are complete.
Available to whom?
Interested researcher may submit analysis plans to Yale Open Data Access program
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://yoda.yale.edu/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04062630