iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

Phase 4

Active, not recruiting

• Conditions: Sacroiliac Joint Dysfunction; Sacroiliac; Fusion; Sacroiliac Disorder; Sacroiliac Joint Pain
• Interventions: Device: Use of iFuse TORQ

• Registration Number: NCT05870488
• Lead Sponsor: SI-BONE, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-12
• Study Start: 2023-05-23
• Study First Posted: 2023-05-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-05
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of iFuse TORQ for SI Joint Fusion	Use of iFuse TORQ	Participants with SI joint dysfunction are treated with iFuse TORQ.

Primary Outcome Measures

Name	Time	Method
Change in SI joint pain measured by numerical rating scale (NRS)	At baseline and 6 months	Change in SI joint pain measured by NRS (0- no pain to 10- worst pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Improvement from baseline in quality of life	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.
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
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 disability	At baseline, 1-, 3-, 6-, 12-, and 24-months	Improvement from baseline in disability as measured by Oswestry Disability Index
Improvement from baseline in SI joint (SIJ) pain	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).
Evidence of bone binding	At baseline and 24 months	Evidence of bone binding to at least 50% of the porous surface area of each implanted device
Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation	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

Trial Locations

Locations (14)

Napa Valley Orthopaedics; 🇺🇸 Napa, California, United States

Source Healthcare; 🇺🇸 Santa Monica, California, United States

Comprehensive Pain and Spine Specialists; 🇺🇸 Shelbyville, Indiana, United States

Ascentist Healthcare; 🇺🇸 Leawood, Kansas, United States

Crimson Pain Management; 🇺🇸 Overland Park, Kansas, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Clearway Pain; 🇺🇸 Annapolis, Maryland, United States

St Louis Pain Consultants; 🇺🇸 Chesterfield, Missouri, United States

Nevada Advanced Pain; 🇺🇸 Reno, Nevada, United States

Clinical Investigations; 🇺🇸 Edmond, Oklahoma, United States

Neurological Associates of Lancaster; 🇺🇸 Lancaster, Pennsylvania, United States

Advanced Pain Institute of Texas; 🇺🇸 Lewisville, Texas, United States

Anesis Spine & Pain Care; 🇺🇸 Renton, Washington, United States

Pro Spine and Pain; 🇺🇸 Milwaukee, Wisconsin, United States