Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

NCT01640353 | Completed Results

• 1 other identifier: 300101
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 26

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)

  24 months

• Change in Back Dysfunction

  24 months

• Change in Quality of Life

  Baseline and 24 months

• Ambulatory Status

  24 months

• Work Status

  Basline, 24 months

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. 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

You may not qualify if:

• 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:
• Sacral dysplasia
• Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)
• Tumor
• Infection
• Acute fracture
• 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

Sponsors & Collaborators

• SI-BONE, Inc.: lead

Study Sites (26)

Spine and Neuro Center

Huntsville, Alabama, 35801, United States

Location

Silicon Valley Spine

Campbell, California, 95008, United States

Location

BASIC Spine

Newport Beach, California, 92660, United States

Location

Southern California Center for Neuroscience and Spine (SCCNS)

Pomona, California, 91767, United States

Location

St. Mary's Spine

San Francisco, California, 94117, United States

Location

Neurosurgical and Spine Specialists

Parker, Colorado, 80138, United States

Location

Orthopaedic Clinic of Daytona Beach

Daytona Beach, Florida, 32117, United States

Location

The Orthopaedic Institute/NFRMC

Gainsville, Florida, 32607, United States

Location

Bartow Regional Medical Center

Lakeland, Florida, 33806, United States

Location

Piedmont Orhopaedics

Macon, Georgia, 31210, United States

Location

Orthopaedic Center of Southern Illinois

Mount Vernon, Illinois, 62864, United States

Location

Bluegrass Orthopaedics & Hand Care Research

Lexington, Kentucky, 40509, United States

Location

Columbia Orthopaedic Group

Columbia, Missouri, 65201, United States

Location

Midwest Division-RMC, LLC,-Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Mercy Medical Research Institute

Springfield, Missouri, 65807, United States

Location

Alice Peck Day Memorial Hospital

Lebanon, New Hampshire, 03766, United States

Location

Manhattan Orthopedic Spine, PLLC

New York, New York, 10075, United States

Location

Orthopedic and Reconstructive Center (formally)Health Research Institute

Oklahoma City, Oklahoma, 73109, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

East Tennesse Brain & Spine Center

Johnson City, Tennessee, 37064, United States

Location

Brazos Spine

College Station, Texas, 77845, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

Virginia Spine Institute

Reston, Virginia, 20190, United States

Location

Overlake Hospital Medical Center

Bellevue, Washington, 98004, United States

Location

Related Publications (1)

• Dat KO, Cher D, Polly DW. Effects of BMI on SI joint fusion outcomes: examining the evidence to improve insurance guidelines. Spine J. 2024 May;24(5):783-790. doi: 10.1016/j.spinee.2023.11.015. Epub 2023 Dec 9.

  PMID: 38081463 DERIVED

Limitations and Caveats

Lack of concurrent control group undergoing non-surgical treatment and a 24-month follow up rate that was not as high as desired.

Results Point of Contact

• Title: Daniel Cher, MD, Vice President of Clinical Affairs
• Organization: SI-BONE, Inc.

dcher@si-bone.com

650-269-5763

Study Officials

• Bradley Duhon, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 13, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 24, 2017
• Results First Posted: March 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

US (26)