Sacroiliac Joint Fusion With iFuse Implant System (SIFI) (SIFI)

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.

Study Overview

• Status: Completed
• Conditions: Sacroiliac Joint Disruption; Degenerative Sacroiliitis

• Study Type: Observational
• Enrollment (Actual): 194

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Spine and Neuro Center
  • California
    • Campbell, California, United States, 95008
      • Silicon Valley Spine
    • Newport Beach, California, United States, 92660
      • BASIC Spine
    • Pomona, California, United States, 91767
      • Southern California Center for Neuroscience and Spine (SCCNS)
    • San Francisco, California, United States, 94117
      • St. Mary's Spine
  • Colorado
    • Parker, Colorado, United States, 80138
      • Neurosurgical and Spine Specialists
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Orthopaedic Clinic of Daytona Beach
    • Gainsville, Florida, United States, 32607
      • The Orthopaedic Institute/NFRMC
    • Lakeland, Florida, United States, 33806
      • Bartow Regional Medical Center
  • Georgia
    • Macon, Georgia, United States, 31210
      • Piedmont Orhopaedics
  • Illinois
    • Mt. Vernon, Illinois, United States, 62864
      • Orthopaedic Center of Southern Illinois
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Orthopaedics & Hand Care Research
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Orthopaedic Group
    • Kansas City, Missouri, United States, 64132
      • Midwest Division-RMC, LLC,-Research Medical Center
    • Springfield, Missouri, United States, 65807
      • Mercy Medical Research Institute
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Alice Peck Day Memorial Hospital
  • New York
    • New York, New York, United States, 10075
      • Manhattan Orthopedic Spine, PLLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Orthopedic and Reconstructive Center (formally)Health Research Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Johnson City, Tennessee, United States, 37064
      • East Tennesse Brain & Spine Center
  • Texas
    • College Station, Texas, United States, 77845
      • Brazos Spine
    • Plano, Texas, United States, 75093
      • Texas Back Institute
    • Tyler, Texas, United States, 75701
      • Precision Spine Care
  • Virginia
    • Reston, Virginia, United States, 20190
      • Virginia Spine Institute
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with SI joint pain due to degeneration or disruption of the SI joint

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Success	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.	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)	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.	24 months
Change in Back Dysfunction	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%.	24 months
Change in Quality of Life	Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits	Baseline and 24 months
Ambulatory Status	Percentage of population fully ambulatory at 24 months post operatively.	24 months
Work Status	Proportion of non-working subjects who return to work	Basline, 24 months
Serious Adverse Events	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.	Procedure, discharge, 1,3,6,12,18 and 24 months

Collaborators and Investigators

• Sponsor: SI-BONE, Inc.
• Investigators: Principal Investigator: Bradley Duhon, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (Estimate): July 13, 2012

Study Record Updates

• Last Update Posted (Actual): March 24, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Sacroiliitis
• Other Study ID Numbers: 300101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data is shared with YODA project.