iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

Sacroiliac Joint Dysfunction Clinical Trial

Official title:

iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870488
• Other study ID #: 301140
• Status: Recruiting
• Phase: Phase 4
• Start date: May 23, 2023
• Est. completion date: May 2026

Study information

• Verified date: March 2024
• Source: SI-BONE, Inc.
• Contact: Robyn Capobianco, PhD
• Phone: (408) 207-0700
• Email: robyn.capobianco[@]si-bone.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Joint Diseases
• Sacroiliac Disorder
• Sacroiliac Joint Dysfunction
• Sacroiliac Joint Pain
• Sacroiliac; Fusion

Intervention

Device:
• Use of iFuse TORQ
Use of iFuse TORQ for the treatment of SI Joint dysfunction

Locations

Country	Name	City	State
United States	Clearway Pain	Annapolis	Maryland
United States	Total Spine Institute	Calabasas	California
United States	St Louis Pain Consultants	Chesterfield	Missouri
United States	Clinical Investigations	Edmond	Oklahoma
United States	Neurological Associates of Lancaster	Lancaster	Pennsylvania
United States	Ascentist Healthcare	Leawood	Kansas
United States	Advanced Pain Institute of Texas	Lewisville	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	iSpine	Maple Grove	Minnesota
United States	Pro Spine and Pain	Milwaukee	Wisconsin
United States	Napa Valley Orthopaedics	Napa	California
United States	Crimson Pain Management	Overland Park	Kansas
United States	Nevada Advanced Pain	Reno	Nevada
United States	Anesis Spine & Pain Care	Renton	Washington
United States	Source Healthcare	Santa Monica	California
United States	Comprehensive Pain and Spine Specialists	Shelbyville	Indiana
United States	Northwest Pain Care	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
SI-BONE, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of iFuse TORQ implants that show evidence of device migration		At baseline and 24 months
Secondary	Proportion of iFuse TORQ implants that show breakage		At baseline and 24 months