Sacroiliac Joint DysfunctionPhase 4STACINCT05870488
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
A Phase 4 study testing Use of iFuse TORQ in people with Sacroiliac Joint Dysfunction and Sacroiliac; Fusion, run by SI-BONE, Inc. at 14 sites in United States.
Trial summary
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (STACI) is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sacroiliac Joint Dysfunction, Sacroiliac; Fusion, Sacroiliac Disorder
- What is being tested?
- Use of iFuse TORQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 14 sitesUnited States
- Study dates
- 23 May 2023to Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 21 at time of screening
- Patient has lower back / buttock pain for at least 6 months inadequately responsive to non-surgical care
- Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or sacroiliac disruption)
- Baseline Oswestry Disability Index (ODI) score of at least 30%
- Baseline SIJ pain score of at least 5 on 0-10 numerical rating scale
- BMI < 35
- Patient has signed study-specific informed consent form
Who cannot join
- ASA score 4 or 5
- 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: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture
- Cluneal neuralgia
- Previous SIJ implant placement, including allograft
- Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable device placement
Show all 18Show fewer
- History of recent (<1 year) major trauma to pelvis
- Previously diagnosed or suspected severe osteoporosis (defined as prior T-score < -2.5 or history of osteoporotic fracture).
- Chronic rheumatologic condition (e.g., rheumatoid arthritis)
- Current diagnosis of fibromyalgia
- Known allergy to titanium or titanium alloys
- 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 (self-reported)
- Patient is a prisoner or a ward of the state.
- Known or suspected active drug or alcohol abuse, including opioids
- Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
- Currently participating in another interventional clinical trial
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Clearway Pain
Annapolis, Maryland, 21401
St Louis Pain Consultants
Chesterfield, Missouri, 63017
Clinical Investigations
Edmond, Oklahoma, 73034
Neurological Associates of Lancaster
Lancaster, Pennsylvania, 17601
Ascentist Healthcare
Leawood, Kansas, 66211
Advanced Pain Institute of Texas
Lewisville, Texas, 75057
University of Kentucky
Lexington, Kentucky, 40504
Pro Spine and Pain
Milwaukee, Wisconsin, 53221
Napa Valley Orthopaedics
Napa, California, 94558
Crimson Pain Management
Overland Park, Kansas, 66209
Nevada Advanced Pain
Reno, Nevada, 89511
Anesis Spine & Pain Care
Renton, Washington, 98057
Source Healthcare
Santa Monica, California, 90403
Comprehensive Pain and Spine Specialists
Shelbyville, Indiana, 46176
About this study
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (STACI) is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.
Read the detailed description
This trial is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system. The goal of the trial is to demonstrate the effectiveness of the device for its intended use.
- Conditions
- Sacroiliac Joint Dysfunction, Sacroiliac; Fusion, Sacroiliac Disorder, Sacroiliac Joint Pain
- Being tested
- Use of iFuse TORQ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of iFuse TORQDevice
Use of iFuse TORQ for the treatment of SI Joint dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Use of iFuse TORQ for SI Joint Fusion | Other | Participants with SI joint dysfunction are treated with iFuse TORQ. Receives: Device: Use of iFuse TORQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SI joint pain measured by numerical rating scale (NRS)
Change in SI joint pain measured by NRS (0- no pain to 10- worst pain imaginable)
Measured: At baseline and 6 months
Secondary outcomes (8)
Improvement from baseline in SI joint (SIJ) pain
Improvement from baseline in SIJ pain as measured by numeric rating scale (0- no pain to 10- worst pain imaginable).
Measured: At baseline, 1-, 3-, 6-, 12-, and 24-months
Improvement from baseline in disability
Improvement from baseline in disability as measured by Oswestry Disability Index
Measured: At baseline, 1-, 3-, 6-, 12-, and 24-months
Improvement from baseline in quality of life
Improvement from baseline in aggregate quality of life and individual domains as measured by PROMIS-29.
Measured: At baseline, 1-, 3-, 6-, 12-, and 24-months
Proportion of subjects with a complication rated as probably or definitely related to the procedure or device.
Measured: At baseline, 1-, 3-, 6-, 12-, and 24-months
Evidence of bone binding
Evidence of bone binding to at least 50% of the porous surface area of each implanted device
Measured: At baseline and 24 months
Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation
Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation, as evidenced by both radiopaque areas around implant plus bony reaction ("rind") near implant
Measured: At baseline and 24 months
Proportion of iFuse TORQ implants that show evidence of device migration
Measured: At baseline and 24 months
Proportion of iFuse TORQ implants that show breakage
Measured: At baseline 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 posted23 May 2023
- Study start23 May 2023
- Primary completion23 Apr 2025
- Study completionNov 2027 (estimated)
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 Sacroiliac Joint DysfunctionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SI-BONE, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacie Tran, MPH, Study director, SI-BONE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870488
- Sponsor's protocol ID
- 301140
- Acronym
- STACI
- Status last verified
- Feb 2026
- First submitted
- 12 May 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Weisbein J, Patterson D, Beall D, Nguyen D, Smith J, Harstroem C, Davis T, Foster J, Christopher A, Kloster D, Broadnax J, Anderson E, Hatheway J, Trobridge A, Simmons C, Stauss T, Harned M, Mallard C. Safety and initial effectiveness of minimally invasive sacroiliac joint fusion with metal implants using a lateral transiliac approach: a prospective trial. Pain Med. 2025 Dec 1;26(12):918-923. doi: 10.1093/pm/pnaf082.
PubMed 40574607
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT05870488
- Acronym / sponsor ID
- STACI / 301140
- Conditions
- Sacroiliac Joint Dysfunction, Sacroiliac; Fusion, Sacroiliac Disorder, Sacroiliac Joint Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- SI-BONE, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 May 2023 (actual)
- 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.
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (STACI) is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.
Detailed description
This trial is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system. The goal of the trial is to demonstrate the effectiveness of the device for its intended use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of iFuse TORQ for SI Joint Fusion | Other | Device: Use of iFuse TORQParticipants with SI joint dysfunction are treated with iFuse TORQ. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 21 at time of screening
- Patient has lower back / buttock pain for at least 6 months inadequately responsive to non-surgical care
- Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or sacroiliac disruption)
- Baseline Oswestry Disability Index (ODI) score of at least 30%
- Baseline SIJ pain score of at least 5 on 0-10 numerical rating scale
Key exclusion criteria (18 listed)
- ASA score 4 or 5
- 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: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture
- Cluneal neuralgia
- Previous SIJ implant placement, including allograft
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 |
|---|---|---|
| Use of iFuse TORQUse of iFuse TORQ for the treatment of SI Joint dysfunction | Device | Use of iFuse TORQ for SI Joint Fusion |
Primary outcome
Change in SI joint pain measured by numerical rating scale (NRS)
Time frame: At baseline and 6 months
Change in SI joint pain measured by NRS (0- no pain to 10- worst pain imaginable)
8 secondary outcomes
Improvement from baseline in SI joint (SIJ) pain
Time frame: At baseline, 1-, 3-, 6-, 12-, and 24-months
Improvement from baseline in disability
Time frame: At baseline, 1-, 3-, 6-, 12-, and 24-months
Improvement from baseline in quality of life
Time frame: At baseline, 1-, 3-, 6-, 12-, and 24-months
Proportion of subjects with a complication rated as probably or definitely related to the procedure or device.
Time frame: At baseline, 1-, 3-, 6-, 12-, and 24-months
Evidence of bone binding
Time frame: At baseline and 24 months
Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation
Time frame: At baseline and 24 months
Proportion of iFuse TORQ implants that show evidence of device migration
Time frame: At baseline and 24 months
Proportion of iFuse TORQ implants that show breakage
Time frame: At baseline and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 40574607Weisbein J, Patterson D, Beall D, Nguyen D, Smith J, Harstroem C, Davis T, Foster J, Christopher A, Kloster D, Broadnax J, Anderson E, Hatheway J, Trobridge A, Simmons C, Stauss T, Harned M, Mallard C. Safety and initial effectiveness of minimally invasive sacroiliac joint fusion with metal implants using a lateral transiliac approach: a prospective trial. Pain Med. 2025 Dec 1;26(12):918-923. doi: 10.1093/pm/pnaf082.
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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.
Stacie Tran, MPH study director
SI-BONE
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Use of iFuse TORQ in people with Sacroiliac Joint Dysfunction and Sacroiliac; Fusion, run by SI-BONE, Inc. at 14 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 7 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in SI joint pain measured by numerical rating scale (NRS) (time frame: At 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 NCT05870488, 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 2026.