iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

NCT05870488 | Active Not Recruiting Phase 4 DMC FDA Device

• 1 other identifier: 301140
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Sacroiliac Joint Dysfunction; Sacroiliac; Fusion; Sacroiliac Disorder; Sacroiliac Joint Pain

Outcome Measures

Primary Outcomes (1)

• 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)

  At baseline and 6 months

Secondary Outcomes (8)

• Improvement from baseline in SI joint (SIJ) pain

  At baseline, 1-, 3-, 6-, 12-, and 24-months

• Improvement from baseline in disability

  At baseline, 1-, 3-, 6-, 12-, and 24-months

• Improvement from baseline in quality of life

  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.

  At baseline, 1-, 3-, 6-, 12-, and 24-months

• Evidence of bone binding

  At baseline and 24 months

Study Arms (1)

Use of iFuse TORQ for SI Joint Fusion

OTHER

Participants with SI joint dysfunction are treated with iFuse TORQ.

Device: Use of iFuse TORQ

Interventions

Use of iFuse TORQ DEVICE

Use of iFuse TORQ for the treatment of SI Joint dysfunction

Use of iFuse TORQ for SI Joint Fusion

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SI-BONE, Inc.: lead

Study Sites (14)

Napa Valley Orthopaedics

Napa, California, 94558, United States

Location

Source Healthcare

Santa Monica, California, 90403, United States

Location

Comprehensive Pain and Spine Specialists

Shelbyville, Indiana, 46176, United States

Location

Ascentist Healthcare

Leawood, Kansas, 66211, United States

Location

Crimson Pain Management

Overland Park, Kansas, 66209, United States

Location

University of Kentucky

Lexington, Kentucky, 40504, United States

Location

Clearway Pain

Annapolis, Maryland, 21401, United States

Location

St Louis Pain Consultants

Chesterfield, Missouri, 63017, United States

Location

Nevada Advanced Pain

Reno, Nevada, 89511, United States

Location

Clinical Investigations

Edmond, Oklahoma, 73034, United States

Location

Neurological Associates of Lancaster

Lancaster, Pennsylvania, 17601, United States

Location

Advanced Pain Institute of Texas

Lewisville, Texas, 75057, United States

Location

Anesis Spine & Pain Care

Renton, Washington, 98057, United States

Location

Pro Spine and Pain

Milwaukee, Wisconsin, 53221, United States

Location

Study Officials

• Stacie Tran, MPH

  SI-BONE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: May 23, 2023
• Primary Completion: April 23, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (14)