Clinical trial NCT04062630: SI Joint Stabilization in Long Fusion to the Pelvis
Official title: Sacroiliac Joint Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Disruption
Scoliosis Lumbar Region
Keywords: Adult Scoliotic Spinal Deformity
Sacroiliac joint pain
multilevel lumbar surgery
SI Joint pain
Lead sponsor: SI-BONE, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-20
Enrollment: 213
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion with S2AI screw abnormality on CT scan
timeFrame: 2 years
measure: Incidence of SI Joint pain
timeFrame: 2 years
measure: Change from baseline in self-reported SI joint pain at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of subjects requiring revision, removal, reoperation or supplemental fixation
timeFrame: 2 years
measure: Therapeutic injection or other non-medication based intervention
timeFrame: 2 years
measure: Oswestry Disability Index
timeFrame: 2 years
measure: EuroQol Group Health Questionnaire
timeFrame: 2 years
measure: Scoliosis Research Society 22r Patient Questionnaire
timeFrame: 2 years
measure: Ambulatory and Work Status
timeFrame: 2 years
measure: Opioid Medication Use
timeFrame: 2 years
measure: Proportion of S2AI screw breakage
timeFrame: 2 years
measure: Proportion of S2AI screw loosening
timeFrame: 2 years
measure: iFuse-3D implant fully seated
timeFrame: 2 years
measure: iFuse-3D implant position
timeFrame: 2 years
measure: Proportion of abnormal bone reactions in the pelvis
timeFrame: 2 years
measure: Change from baseline thoracic kyphosis at 2 years
timeFrame: 2 years
measure: Change from baseline pelvic tilt at 2 years
timeFrame: 2 years
measure: Change from baseline pelvic incidence at 2 years
timeFrame: 2 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Hospital
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
city: San Francisco
country: United States
facility: St Mary's Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Orlando
country: United States
facility: Orlando Health Physician Neurosurgery Group
state: Florida
city: Coeur d'Alene
country: United States
facility: Axis Spine Center
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Regional Medical Center
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Buffalo
country: United States
facility: University of Buffalo Neurosurgery
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Tennessee Orthopaedics Alliance
state: Tennessee
city: Austin
country: United States
facility: Austin Spine
state: Texas
city: Fort Worth
country: United States
facility: North Texas Neurosurgical and Spine Center
state: Texas
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: Charlottesville
country: United States
facility: UVA Spine Center - Ortho
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia - Dept of Neurosurgery
state: Virginia
city: Richmond
country: United States
facility: Ortho Virginia Research Institute
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason
state: Washington
city: Richmond
country: Australia
facility: Epworth HealthCare
state: Victoria
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg
city: Legnano
country: Italy
facility: Ospedale Civile di Legnano- ASST Ovest Milanese
state: Milan
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital
Study officials:
affiliation: SI-BONE
name: Daniel Cher, MD
role: STUDY_DIRECTOR
References: