New implant aims to ease stubborn back pain
NCT ID NCT07565545
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will test a titanium implant designed to fuse the sacroiliac joint in people with chronic lower back pain that hasn't responded to non-surgical treatments. About 120 adults with sacroiliac joint dysfunction will receive the implant and be followed for safety and pain relief. The main goal is to see if the implant reduces pain by at least 2 points on a 10-point scale without causing serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iFuse INTRA Ti Implant System (titanium implant for sacroiliac joint fusion)
- What this could lead to
- If successful, this could provide a safe and effective surgical option for people with chronic 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 conclusive. As with any surgery, there are risks of infection, device-related problems, or no pain relief.
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.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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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.
Who is studied
Patients with sacroiliac joint (SIJ) dysfunction due to degenerative sacroiliitis or sacroiliac joint disruption for at least 6 months refractory to non-surgical care
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 years. 2. Patient has chronic lower back pain (≥6 months) refractory to non-surgical care. 3. Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or SIJ disruption) and scheduled to be treated with INTRA Ti. 4. Patient has SIJ pain of at least 5 on a 0-10 numeric rating scale (NRS) prior to procedure. 5. Participant 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. Current diagnosis of cluneal neuralgia. 5. Previous SIJ implant placement, including allograft, on the treated (index) side. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Which exercise works best for sacroiliac pain? a Head-to-Head trial
- New implant offers hope for stubborn back pain sufferers
- Hands-On therapy showdown: which technique eases SI joint pain best?