Active — Not RecruitingPhase 4

iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

United States110 participantsStarted 2023-05-23

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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
✕. 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).

What they're measuring

Change in SI joint pain measured by numerical rating scale (NRS)

Timeframe: At baseline and 6 months

Trial details

NCT IDNCT05870488

SponsorSI-BONE, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-23

View on ClinicalTrials.gov More Sacroiliac Joint Dysfunction trials