iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.

Study Overview

• Status: Recruiting
• Conditions: Sacroiliac Joint Pain; Sacroiliac Joint Dysfunction; Sacroiliac Disorder; Sacroiliac; Fusion
• Intervention / Treatment: Device: Use of iFuse TORQ

Detailed Description

STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system. The goal of the study is to demonstrate the effectiveness of the device for its intended use.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Robyn Capobianco, PhD; Phone Number: (408) 207-0700; Email: robyn.capobianco@si-bone.com

Study Locations

• United States
  • California
    • Calabasas, California, United States, 91302
      • Withdrawn
      • Total Spine Institute
    • Napa, California, United States, 94558
      • Recruiting
      • Napa Valley Orthopaedics
      • Contact: Sarah Porter
      • Principal Investigator: Jacqueline Weisbein, DO
    • Santa Monica, California, United States, 90403
      • Recruiting
      • Source Healthcare
      • Principal Investigator: Timothy Davis, MD
      • Contact: Timothy Davis, MD
  • Indiana
    • Shelbyville, Indiana, United States, 46176
      • Recruiting
      • Comprehensive Pain and Spine Specialists
      • Contact: Erika Stogsdill
      • Principal Investigator: Andrew Trobridge, MD
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Recruiting
      • Ascentist Healthcare
      • Contact: Howard LaRue
      • Principal Investigator: Jeffrey Foster, MD
    • Overland Park, Kansas, United States, 66209
      • Recruiting
      • Crimson Pain Management
      • Contact: Morteza Rabii
      • Principal Investigator: Daniel Kloster, MD
      • Sub-Investigator: Jason Barnes, DO
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Recruiting
      • University of Kentucky
      • Contact: Amy Banfield
      • Principal Investigator: Chris Mallard, MD
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Recruiting
      • Clearway Pain
      • Contact: June Redding
      • Principal Investigator: Charles Simmons, MD
  • Minnesota
    • Maple Grove, Minnesota, United States, 55369
      • Recruiting
      • iSpine
      • Contact: William Saathoff
      • Principal Investigator: Rano Faltas, MD
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Recruiting
      • St Louis Pain Consultants
      • Principal Investigator: Anne Christopher, MD
      • Contact: Olayinka Idowu
  • Nevada
    • Reno, Nevada, United States, 89511
      • Recruiting
      • Nevada Advanced Pain
      • Principal Investigator: Denis Patterson, DO
      • Contact: Logan Lorentzen
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • Recruiting
      • Clinical Investigations
      • Contact: Jennifer Whiterby
      • Principal Investigator: Doug Beall, MD
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Recruiting
      • Neurological Associates of Lancaster
      • Contact: Jack Smith, MD
      • Principal Investigator: Jack Smith, MD
  • Texas
    • Lewisville, Texas, United States, 75057
      • Recruiting
      • Advanced Pain Institute of Texas
      • Contact: Lisa McQueen
      • Principal Investigator: John Broadnax, MD
  • Washington
    • Renton, Washington, United States, 98057
      • Recruiting
      • Anesis Spine & Pain Care
      • Contact: Ashley Colosimo
      • Principal Investigator: Caroline Harstroem, MD
    • Spokane, Washington, United States, 99201
      • Recruiting
      • Northwest Pain Care
      • Principal Investigator: John Hatheway, MD
      • Contact: Lisa Hill
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53221
      • Recruiting
      • Pro Spine and Pain
      • Principal Investigator: Thomas Stauss, MD
      • Contact: Nicholas Giebel, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Use of iFuse TORQ for SI Joint Fusion; Participants with SI joint dysfunction are treated with iFuse TORQ.	Device: Use of iFuse TORQ; Use of iFuse TORQ for the treatment of SI Joint dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement from baseline in disability	Improvement from baseline in disability as measured by Oswestry Disability Index	At baseline, 1-, 3-, 6-, 12-, and 24-months
Improvement from baseline in quality of life	Improvement from baseline in aggregate quality of life and individual domains as measured by PROMIS-29.	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	Evidence of bone binding to at least 50% of the porous surface area of each implanted device	At baseline and 24 months
Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation	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	At baseline and 24 months
Proportion of iFuse TORQ implants that show evidence of device migration		At baseline and 24 months
Proportion of iFuse TORQ implants that show breakage		At baseline and 24 months
Improvement from baseline in SI joint (SIJ) pain	Improvement from baseline in SIJ pain as measured by numeric rating scale (0- no pain to 10- worst pain imaginable).	At baseline, 1-, 3-, 6-, 12-, and 24-months

Collaborators and Investigators

• Sponsor: SI-BONE, Inc.
• Investigators: Study Director: Robyn Capobianco, PhD, SI-BONE

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Arthralgia; Joint Diseases
• Other Study ID Numbers: 301140

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No