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New implant aims to fuse painful pelvic joint

NCT ID NCT05870488

Disease control Sponsor: SI-BONE, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests a device called iFuse TORQ, which is surgically implanted to fuse the sacroiliac joint—a common source of lower back and buttock pain. The trial includes 110 adults who have had pain for at least 6 months and haven't found relief from non-surgical treatments. Researchers will measure changes in pain and disability over time to see if the implant helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iFuse TORQ implant (a medical device used to fuse the sacroiliac joint)
What this could lead to
If successful, this could offer a surgical option for people with long-term sacroiliac joint pain that hasn't improved with other treatments.
What could go wrong
This is a single-arm study without a comparison group, so results may be less reliable. The implant is a surgical procedure, which carries risks like infection or nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age \> 21 at time of screening 2. Patient has lower back / buttock pain for at least 6 months inadequately responsive to non-surgical care 3. Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or sacroiliac disruption) 4. Baseline Oswestry Disability Index (ODI) score of at least 30% 5. Baseline SIJ pain score of at least 5 on 0-10 numerical rating scale 6. BMI \< 35 7. Patient has signed study-specific informed consent form Exclusion Criteria: 1. ASA score 4 or 5 2. 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 3. Other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture 4. Cluneal neuralgia 5. Previous SIJ implant placement, including allograft 6. Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable device placement 7. History of recent (\<1 year) major trauma to pelvis 8. Previously diagnosed or suspected severe osteoporosis (defined as prior T-score \< -2.5 or history of osteoporotic fracture). 9. Chronic rheumatologic condition (e.g., rheumatoid arthritis) 10. Current diagnosis of fibromyalgia 11. Known allergy to titanium or titanium alloys 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 (self-reported) 15. Patient is a prisoner or a ward of the state. 16. Known or suspected active drug or alcohol abuse, including opioids 17. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation 18. Currently participating in another interventional clinical trial

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Conditions

The condition(s) this trial relates to.

arthritis, sacroiliac

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sacroiliac disorder Sacroiliac joint dysfunction Sacroiliac joint pain Sacroiliac; fusion

Contacts and locations

Locations

  • Advanced Pain Institute of Texas

    Lewisville, Texas, 75057, United States

  • Anesis Spine & Pain Care

    Renton, Washington, 98057, United States

  • Ascentist Healthcare

    Leawood, Kansas, 66211, United States

  • Clearway Pain

    Annapolis, Maryland, 21401, United States

  • Clinical Investigations

    Edmond, Oklahoma, 73034, United States

  • Comprehensive Pain and Spine Specialists

    Shelbyville, Indiana, 46176, United States

  • Crimson Pain Management

    Overland Park, Kansas, 66209, United States

  • Napa Valley Orthopaedics

    Napa, California, 94558, United States

  • Neurological Associates of Lancaster

    Lancaster, Pennsylvania, 17601, United States

  • Nevada Advanced Pain

    Reno, Nevada, 89511, United States

  • Pro Spine and Pain

    Milwaukee, Wisconsin, 53221, United States

  • Source Healthcare

    Santa Monica, California, 90403, United States

  • St Louis Pain Consultants

    Chesterfield, Missouri, 63017, United States

  • University of Kentucky

    Lexington, Kentucky, 40504, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.