Clinical trial NCT01640353: Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
Official title: Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Sacroiliitis
Sacroiliac Joint Disruption
Keywords: si joint
si joint pain
si joint injury
si joint treatment
si joint injections
si joint inflammation
si joint problems
si joint symptoms
hypermobile si joint
si joint arthritis
si joint pain treatment
inflamed si joint
si joint sclerosis
locked si joint
si joint injuries
si joint disease
si joint infection
sacroiliac joint pelvic pain
sacroiliac joint arthritis treatment
Lead sponsor: SI-BONE, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-13
Enrollment: 194
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with SI joint pain due to degeneration or disruption of the SI joint

Brief summary: The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is a medical device that is surgically implanted into the sacroiliac (SI) joint during a minimally invasive surgical procedure (one that uses a smaller incision and less damage to the skin and other tissues than standard surgery). The purpose of implanting the device is to stabilize and fuse the SI joint.


Eligibility criteria: Inclusion Criteria:

1. Age 21-70 at time of screening

2. Patient has lower back pain for \>6 months inadequately responsive to conservative care

3. Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:

1. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and
2. Patient has at least 3 of 5 physical examination maneuvers specific for the SI joint (see Table 3), and
3. Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50% after injection of local anesthetic into affected SI joint(s) (see Section 3.6.4), and
4. One or more of the following:

i. SI joint disruption:

1. Asymmetric SI joint widening on X-ray or CT scan
2. Leakage of contrast on diagnostic arthrography

ii. Degenerative sacroiliitis:

1. Radiographic evidence of SI joint degeneration, including sclerosis,osteophytes, subchondral cysts, or vacuum phenomenon on CT or plain film, or
2. Due to prior lumbosacral spine fusion

4. Baseline Oswestry Disability Index (ODI) score of at least 30% 5. Baseline SI joint pain score of at least 50 on 0-100 mm visual analog scale 6. Patient has signed study-specific informed consent form 7. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion Criteria:

1. Severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture
2. Other known sacroiliac pathology such as:

   1. Sacral dysplasia
   2. Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)
   3. Tumor
   4. Infection
   5. Acute fracture
   6. Crystal arthropathy
3. History of recent (\< 1 year) major trauma to pelvis
4. Previously diagnosed osteoporosis (defined as prior T-score \<-2.5 or history of osteoporotic fracture).
5. Osteomalacia or other metabolic bone disease
6. Chronic rheumatologic condition (e.g., rheumatoid arthritis)
7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
8. Chondropathy
9. Known allergy to titanium or titanium alloys
10. Use of medications known to have detrimental effects on bone quality and soft-tissue healing
11. Prominent neurologic condition that would interfere with physical therapy
12. Current local or systemic infection that raises the risk of surgery
13. Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
14. Currently pregnant or planning pregnancy in the next 2 years
15. Patient is a prisoner or a ward of the state.
16. Known or suspected drug or alcohol abuse
17. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
18. Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation

Primary outcomes:
measure: Subject Success
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)
timeFrame: 24 months
measure: Change in Back Dysfunction
timeFrame: 24 months
measure: Change in Quality of Life
timeFrame: Baseline and 24 months
measure: Ambulatory Status
timeFrame: 24 months
measure: Work Status
timeFrame: Basline, 24 months
measure: Serious Adverse Events
timeFrame: Procedure, discharge, 1,3,6,12,18 and 24 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Spine and Neuro Center
state: Alabama
city: Campbell
country: United States
facility: Silicon Valley Spine
state: California
city: Newport Beach
country: United States
facility: BASIC Spine
state: California
city: Pomona
country: United States
facility: Southern California Center for Neuroscience and Spine (SCCNS)
state: California
city: San Francisco
country: United States
facility: St. Mary's Spine
state: California
city: Parker
country: United States
facility: Neurosurgical and Spine Specialists
state: Colorado
city: Daytona Beach
country: United States
facility: Orthopaedic Clinic of Daytona Beach
state: Florida
city: Gainsville
country: United States
facility: The Orthopaedic Institute/NFRMC
state: Florida
city: Lakeland
country: United States
facility: Bartow Regional Medical Center
state: Florida
city: Macon
country: United States
facility: Piedmont Orhopaedics
state: Georgia
city: Mt. Vernon
country: United States
facility: Orthopaedic Center of Southern Illinois
state: Illinois
city: Lexington
country: United States
facility: Bluegrass Orthopaedics & Hand Care Research
state: Kentucky
city: Columbia
country: United States
facility: Columbia Orthopaedic Group
state: Missouri
city: Kansas City
country: United States
facility: Midwest Division-RMC, LLC,-Research Medical Center
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Lebanon
country: United States
facility: Alice Peck Day Memorial Hospital
state: New Hampshire
city: New York
country: United States
facility: Manhattan Orthopedic Spine, PLLC
state: New York
city: Oklahoma City
country: United States
facility: Orthopedic and Reconstructive Center (formally)Health Research Institute
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Johnson City
country: United States
facility: East Tennesse Brain & Spine Center
state: Tennessee
city: College Station
country: United States
facility: Brazos Spine
state: Texas
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Reston
country: United States
facility: Virginia Spine Institute
state: Virginia
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
Study officials:
affiliation: University of Colorado, Denver
name: Bradley Duhon, MD
role: PRINCIPAL_INVESTIGATOR
References: