Degenerative SacroiliitisSIFINCT01640353
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
An observational study of Degenerative Sacroiliitis and Sacroiliac Joint Disruption, run by SI-BONE, Inc. at 26 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Degenerative Sacroiliitis, Sacroiliac Joint Disruption
- How many people
- 194 participants
- Where
- 26 sitesUnited States
- Study dates
- Jul 2012to Feb 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with SI joint pain due to degeneration or disruption of the SI joint
Who may be able to join
- 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:
- 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
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- One or more of the following:
- SI joint disruption:
- Asymmetric SI joint widening on X-ray or CT scan
- Leakage of contrast on diagnostic arthrography
- 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
- 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
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Overlake Hospital Medical Center
Bellevue, Washington, 98004
Silicon Valley Spine
Campbell, California, 95008
Medical University of South Carolina
Charleston, South Carolina, 29425
Brazos Spine
College Station, Texas, 77845
Columbia Orthopaedic Group
Columbia, Missouri, 65201
Orthopaedic Clinic of Daytona Beach
Daytona Beach, Florida, 32117
The Orthopaedic Institute/NFRMC
Gainsville, Florida, 32607
Spine and Neuro Center
Huntsville, Alabama, 35801
East Tennesse Brain & Spine Center
Johnson City, Tennessee, 37064
Midwest Division-RMC, LLC,-Research Medical Center
Kansas City, Missouri, 64132
Bartow Regional Medical Center
Lakeland, Florida, 33806
Alice Peck Day Memorial Hospital
Lebanon, New Hampshire, 03766
Bluegrass Orthopaedics & Hand Care Research
Lexington, Kentucky, 40509
Piedmont Orhopaedics
Macon, Georgia, 31210
Orthopaedic Center of Southern Illinois
Mount Vernon, Illinois, 62864
Manhattan Orthopedic Spine, PLLC
New York, New York, 10075
BASIC Spine
Newport Beach, California, 92660
Orthopedic and Reconstructive Center (formally)Health Research Institute
Oklahoma City, Oklahoma, 73109
Neurosurgical and Spine Specialists
Parker, Colorado, 80138
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Texas Back Institute
Plano, Texas, 75093
Southern California Center for Neuroscience and Spine (SCCNS)
Pomona, California, 91767
Virginia Spine Institute
Reston, Virginia, 20190
St. Mary's Spine
San Francisco, California, 94117
Mercy Medical Research Institute
Springfield, Missouri, 65807
Precision Spine Care
Tyler, Texas, 75701
About this study
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.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (6)
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.
Measured: 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%.
Measured: 24 months
Change in Quality of Life
Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits
Measured: Baseline and 24 months
Ambulatory Status
Percentage of population fully ambulatory at 24 months post operatively.
Measured: 24 months
Work Status
Proportion of non-working subjects who return to work
Measured: 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.
Measured: Procedure, discharge, 1,3,6,12,18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative SacroiliitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- SI-BONE, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bradley Duhon, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640353
- Sponsor's protocol ID
- 300101
- Acronym
- SIFI
- Status last verified
- Feb 2017
- First submitted
- 6 Jul 2012
- Last updated
- 24 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data is shared with YODA project.
Publications
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.
PubMed 38081463
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
- ClinicalTrials.gov ID
- NCT01640353
- Acronym / sponsor ID
- SIFI / 300101
- Keywords
- si joint, si joint pain, si joint injury, si joint treatment, si joint injections, si joint inflammation, si joint problems, si joint symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- SI-BONE, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Posted 24 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with SI joint pain due to degeneration or disruption of the SI joint
Key inclusion criteria (14 listed)
- 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:
- 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
Key exclusion criteria (24 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subject Success
Time frame: 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.
6 secondary outcomes
Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)
Time frame: 24 months
Change in Back Dysfunction
Time frame: 24 months
Change in Quality of Life
Time frame: Baseline and 24 months
Ambulatory Status
Time frame: 24 months
Work Status
Time frame: Basline, 24 months
Serious Adverse Events
Time frame: Procedure, discharge, 1,3,6,12,18 and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38081463Dat 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.
- Individual participant dataSharing planned: Yes. Data is shared with YODA project.
Related trials for Degenerative Sacroiliitis
Enrolling by invitationObservational study
Sacroiliac Joint Fusion Intervention For Mobility, Pain Relief, and Lasting Improvement in Functional Recovery "SIMPLIFY"
Degenerative Sacroiliitis, Sacroiliac Disorder
Not yet recruitingObservational study
Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes
Sacro Iliac Joint Pain, Sacro-iliac Joints
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Duhon, MD principal investigator
University of Colorado, Denver
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Sacroiliitis and Sacroiliac Joint Disruption, run by SI-BONE, Inc. at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Success (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01640353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.