Degenerative SacroilitisLOISNCT02270203
LOIS: Long-Term Follow-Up in INSITE/SIFI
An observational study of Degenerative Sacroilitis and Sacroiliac Joint Disruption, run by SI-BONE, Inc. at 12 sites in United States.
Trial summary
The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Degenerative Sacroilitis, Sacroiliac Joint Disruption
- What is being tested?
- Pelvic CT at 5 years post-op
- Type of treatment
- Surgery or procedure
- How many people
- 103 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2014to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement.
Who may be able to join
- Patient enrolled and treated in SIFI or patient initially randomized to iFuse and treated in INSITE. Note: Patient may be in the initial follow up period associated with SIFI or INSITE at the same time they consent for this study and "extend" their post-operative follow up.
- Patient has signed study-specific LOIS informed consent form.
- Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.
Who cannot join
- Treated with iFuse as a "crossover" in INSITE.
- Currently pregnant or planning pregnancy within 5 years of iFuse Implant.
- Patient is a prisoner or a ward of the state.
- Known or suspected active drug or alcohol abuse.
- Inadequately treated psychiatric illness (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
- Unwilling to perform the long-term follow up requirements of this study.
- Patient has any condition that could substantially prevent long-term follow-up.
- Unwilling to return to site at pre-specified study visits.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Overlake Hospital Medical Center
Bellevue, Washington, 98004
MUSC
Charleston, South Carolina, 29425
Columbia Orthopaedic Group
Columbia, Missouri, 65201
Aurora Research Institute
Green Bay, Wisconsin, 54311
Bluegrass Orthopaedics & Hand Care
Lexington, Kentucky, 40509
Orthopaedic Center of Southern Illinois
Mount Vernon, Illinois, 62864
Yale University School of Medicine
New Haven, Connecticut, 06510
Oklahoma Center for Spine & Pain Solutions
Oklahoma City, Oklahoma, 73159
Allegheny Medical Center
Pittsburgh, Pennsylvania, 15212
Regenerative Orthopaedics and Spine Institute
Stockbridge, Georgia, 30281
Precision Spine Care
Tyler, Texas, 75701
Integrated Spine Care
Wauwatosa, Wisconsin, 53132
About this study
The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD).
Study Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System). The two ongoing trials are:
- SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement, and
- INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the same patient population who underwent either non-surgical treatment or iFuse placement
- Being tested
- Pelvic CT at 5 years post-op
- Keywords
- si joint, si joint injury, si joint treatment, si joint inflammation, si joint problems, si joint symptoms, hypermobile 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, si joint pain, si joint injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic CT at 5 years post-opRadiation
Pelvic CT at 5 years post-op
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Success
Composite endpoint of success defined as improvement in VAS (Visual Analog Scale) recorded at SIFI or INSITE Baseline VAS back pain score by ≥20 mm; Absence of device-related SAE (Serious Adverse Events) ; Absence of neurological worsening related to the sacral spine,\& Absence of surgical re-intervention on the target SI joint(s).
Measured: 3 years on LOIS (5 years post-op)
Radiographic (CT) apposition of bone to sacral and iliac sides of implant
Proportion of subjects (with CT) who had at least 30% apposition of bone to sacral and iliac sides in at least 2 of 3 iFuse implants.
Measured: 3 years on LOIS (5 years post-op)
Secondary outcomes (6)
VAS (Visual Analog Scale)
Improvement in VAS (Visual Analog Scale), SI joint pain at follow-up visits.
Measured: 3 years on LOIS (5 years post-op)
Oswestry Disability Index (ODI) Questionnaire
Improvement in Oswestry Disability Index (ODI) at follow-up visits.
Measured: 3 years on LOIS (5 years post-op)
Improvement in quality of life (QOL)
Improvement in quality of life as measure by EQ-5D Questionnaire at follow-up visits.
Measured: 3 years on LOIS (5 years post-op)
non-working subjects returning to work
Proportion of non-working subjects who return to work
Measured: 3 years on LOIS (5 years post-op)
CT scans showing bridging bone
Proportion of CT scans that show bridging bone across the SI joint at 5 years post-operatively
Measured: 3 years on LOIS (5 years post-op)
SAE (Serious Adverse Events) occurrence rate
Occurrence rate of serious adverse events.
Measured: 3 years on LOIS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative SacroilitisStudies 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- SI-BONE, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Cher, MD, Study director, SI-BONE, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270203
- Sponsor's protocol ID
- 300244
- Acronym
- LOIS
- Status last verified
- Aug 2019
- First submitted
- 16 Oct 2014
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Darr E, Cher D. Four-year outcomes after minimally invasive transiliac sacroiliac joint fusion with triangular titanium implants. Med Devices (Auckl). 2018 Aug 29;11:287-289. doi: 10.2147/MDER.S179003. eCollection 2018.
PubMed 30214322
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOIS: Long-Term Follow-Up in INSITE/SIFI
- ClinicalTrials.gov ID
- NCT02270203
- Acronym / sponsor ID
- LOIS / 300244
- Keywords
- si joint, si joint injury, si joint treatment, si joint inflammation, si joint problems, si joint symptoms, hypermobile joint, si joint arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- SI-BONE, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
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 long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD).
Study Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System). The two ongoing trials are:
- SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement, and
- INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the same patient population who underwent either non-surgical treatment or iFuse placement
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 degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement.
Key inclusion criteria (3 listed)
- Patient enrolled and treated in SIFI or patient initially randomized to iFuse and treated in INSITE. Note: Patient may be in the initial follow up period associated with SIFI or INSITE at the same time they consent for this study and "extend" their post-operative follow up.
- Patient has signed study-specific LOIS informed consent form.
- Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.
Key exclusion criteria (8 listed)
- Treated with iFuse as a "crossover" in INSITE.
- Currently pregnant or planning pregnancy within 5 years of iFuse Implant.
- Patient is a prisoner or a ward of the state.
- Known or suspected active drug or alcohol abuse.
- Inadequately treated psychiatric illness (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic CT at 5 years post-opPelvic CT at 5 years post-op | Radiation | – |
Primary outcome
Subject Success
Time frame: 3 years on LOIS (5 years post-op)
Composite endpoint of success defined as improvement in VAS (Visual Analog Scale) recorded at SIFI or INSITE Baseline VAS back pain score by ≥20 mm; Absence of device-related SAE (Serious Adverse Events) ; Absence of neurological worsening related to the sacral spine,\& Absence of surgical re-intervention on the target SI joint(s).
Radiographic (CT) apposition of bone to sacral and iliac sides of implant
Time frame: 3 years on LOIS (5 years post-op)
Proportion of subjects (with CT) who had at least 30% apposition of bone to sacral and iliac sides in at least 2 of 3 iFuse implants.
6 secondary outcomes
VAS (Visual Analog Scale)
Time frame: 3 years on LOIS (5 years post-op)
Oswestry Disability Index (ODI) Questionnaire
Time frame: 3 years on LOIS (5 years post-op)
Improvement in quality of life (QOL)
Time frame: 3 years on LOIS (5 years post-op)
non-working subjects returning to work
Time frame: 3 years on LOIS (5 years post-op)
CT scans showing bridging bone
Time frame: 3 years on LOIS (5 years post-op)
SAE (Serious Adverse Events) occurrence rate
Time frame: 3 years on LOIS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Derived from this study: PubMed 30214322Darr E, Cher D. Four-year outcomes after minimally invasive transiliac sacroiliac joint fusion with triangular titanium implants. Med Devices (Auckl). 2018 Aug 29;11:287-289. doi: 10.2147/MDER.S179003. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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.
Daniel Cher, MD study director
SI-BONE, Inc.
12 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 Sacroilitis and Sacroiliac Joint Disruption, run by SI-BONE, Inc. at 12 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 3 inclusion and 8 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 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 3 years on LOIS (5 years post-op)). The study lists 2 primary outcomes in all. 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 NCT02270203, 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 6 Aug 2019.