Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

Completed

Conditions: Sacroiliac Joint Disruption
Degenerative Sacroiliitis

Registration Number: NCT01640353

Lead Sponsor: SI-BONE, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 194

Inclusion Criteria

Age 21-70 at time of screening
Patient has lower back pain for >6 months inadequately responsive to conservative care
Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:
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
Patient has at least 3 of 5 physical examination maneuvers specific for the SI joint (see Table 3), and
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
One or more of the following:

i. SI joint disruption:

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

ii. Degenerative sacroiliitis:

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

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subject Success	Baseline and 6 months	Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention.

Secondary Outcome Measures

Name	Time	Method
Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)	24 months	The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain.
Change in Back Dysfunction	24 months	Oswestry Disability Index is a validated patient questionnaire aiming to assess low back pain. The computed scores can be 0% to 100%. Lower scores indicate low disability while high scores indicate high disability. There are 10 questions on the questionnaire. Each has 6 possible answers (0 points - 5 points). If the question is skipped, it's points are subtracted from the denominator. If the raw score is 30 and all 10 questions were answered, the calculation would be 30 / 50 = 60%. If one question was skipped, it would be 30 / 45 = 67%.
Change in Quality of Life	Baseline and 24 months	Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits
Ambulatory Status	24 months	Percentage of population fully ambulatory at 24 months post operatively.
Work Status	Basline, 24 months	Proportion of non-working subjects who return to work
Serious Adverse Events	Procedure, discharge, 1,3,6,12,18 and 24 months	Occurrence of adverse events meeting the ISO14155:2011 definition of serious occurring during the procedure, at the time of hospital discharge (typically day of or next day after procedure), and at various times in late follow-up.

Trial Locations

Locations (26): Mercy Medical Research Institute
🇺🇸
Springfield, Missouri, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Spine and Neuro Center
🇺🇸
Huntsville, Alabama, United States
Silicon Valley Spine
🇺🇸
Campbell, California, United States
BASIC Spine
🇺🇸
Newport Beach, California, United States
Southern California Center for Neuroscience and Spine (SCCNS)
🇺🇸
Pomona, California, United States
Orthopaedic Center of Southern Illinois
🇺🇸
Mt. Vernon, Illinois, United States
Piedmont Orhopaedics
🇺🇸
Macon, Georgia, United States
Columbia Orthopaedic Group
🇺🇸
Columbia, Missouri, United States
St. Mary's Spine
🇺🇸
San Francisco, California, United States
Bluegrass Orthopaedics & Hand Care Research
🇺🇸
Lexington, Kentucky, United States
Manhattan Orthopedic Spine, PLLC
🇺🇸
New York, New York, United States
Midwest Division-RMC, LLC,-Research Medical Center
🇺🇸
Kansas City, Missouri, United States
Orthopedic and Reconstructive Center (formally)Health Research Institute
🇺🇸
Oklahoma City, Oklahoma, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Brazos Spine
🇺🇸
College Station, Texas, United States
Texas Back Institute
🇺🇸
Plano, Texas, United States
Precision Spine Care
🇺🇸
Tyler, Texas, United States
Virginia Spine Institute
🇺🇸
Reston, Virginia, United States
Overlake Hospital Medical Center
🇺🇸
Bellevue, Washington, United States
Neurosurgical and Spine Specialists
🇺🇸
Parker, Colorado, United States
Bartow Regional Medical Center
🇺🇸
Lakeland, Florida, United States
Alice Peck Day Memorial Hospital
🇺🇸
Lebanon, New Hampshire, United States
Orthopaedic Clinic of Daytona Beach
🇺🇸
Daytona Beach, Florida, United States
East Tennesse Brain & Spine Center
🇺🇸
Johnson City, Tennessee, United States
The Orthopaedic Institute/NFRMC
🇺🇸
Gainsville, Florida, United States