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Active, Not Recruiting

NCT Number: NCT05870488

iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (STACI) is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sacroiliac Joint Dysfunction Sacroiliac Disorder Sacroiliac Joint Pain Sacroiliac; Fusion

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Napa Valley Orthopaedics, Napa, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • 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

Treatment and study plan

Use of iFuse TORQ

Device

Use of iFuse TORQ for the treatment of SI Joint dysfunction

Primary outcomes

  1. 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)

Secondary outcomes

  1. Improvement from baseline in SI joint (SIJ) pain

    Time frame: At baseline, 1-, 3-, 6-, 12-, and 24-months

    Improvement from baseline in SIJ pain as measured by numeric rating scale (0- no pain to 10- worst pain imaginable).

  2. Improvement from baseline in disability

    Time frame: At baseline, 1-, 3-, 6-, 12-, and 24-months

    Improvement from baseline in disability as measured by Oswestry Disability Index

  3. Improvement from baseline in quality of life

    Time frame: At baseline, 1-, 3-, 6-, 12-, and 24-months

    Improvement from baseline in aggregate quality of life and individual domains as measured by PROMIS-29.

  4. 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

  5. Evidence of bone binding

    Time frame: At baseline and 24 months

    Evidence of bone binding to at least 50% of the porous surface area of each implanted device

  6. Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation

    Time frame: At baseline and 24 months

    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

  7. Proportion of iFuse TORQ implants that show evidence of device migration

    Time frame: At baseline and 24 months

  8. Proportion of iFuse TORQ implants that show breakage

    Time frame: At baseline and 24 months

Sponsors and collaborators

Lead sponsor

SI-BONE, Inc.

Industry

Registry information

Acronym: STACI

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
May 23, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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