Clinical trial NCT05870488: iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
Official title: iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Sacroiliac Joint Dysfunction
Sacroiliac; Fusion
Sacroiliac Disorder
Sacroiliac Joint Pain
Lead sponsor: SI-BONE, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in SI joint pain measured by numerical rating scale (NRS)
timeFrame: At baseline and 6 months
Secondary outcomes:
measure: Improvement from baseline in SI joint (SIJ) pain
timeFrame: At baseline, 1-, 3-, 6-, 12-, and 24-months
measure: Improvement from baseline in disability
timeFrame: At baseline, 1-, 3-, 6-, 12-, and 24-months
measure: Improvement from baseline in quality of life
timeFrame: At baseline, 1-, 3-, 6-, 12-, and 24-months
measure: Proportion of subjects with a complication rated as probably or definitely related to the procedure or device.
timeFrame: At baseline, 1-, 3-, 6-, 12-, and 24-months
measure: Evidence of bone binding
timeFrame: At baseline and 24 months
measure: Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation
timeFrame: At baseline and 24 months
measure: Proportion of iFuse TORQ implants that show evidence of device migration
timeFrame: At baseline and 24 months
measure: Proportion of iFuse TORQ implants that show breakage
timeFrame: At baseline and 24 months
Other outcomes:
Locations:
city: Napa
country: United States
facility: Napa Valley Orthopaedics
state: California
city: Santa Monica
country: United States
facility: Source Healthcare
state: California
city: Shelbyville
country: United States
facility: Comprehensive Pain and Spine Specialists
state: Indiana
city: Leawood
country: United States
facility: Ascentist Healthcare
state: Kansas
city: Overland Park
country: United States
facility: Crimson Pain Management
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Annapolis
country: United States
facility: Clearway Pain
state: Maryland
city: Chesterfield
country: United States
facility: St Louis Pain Consultants
state: Missouri
city: Reno
country: United States
facility: Nevada Advanced Pain
state: Nevada
city: Edmond
country: United States
facility: Clinical Investigations
state: Oklahoma
city: Lancaster
country: United States
facility: Neurological Associates of Lancaster
state: Pennsylvania
city: Lewisville
country: United States
facility: Advanced Pain Institute of Texas
state: Texas
city: Renton
country: United States
facility: Anesis Spine & Pain Care
state: Washington
city: Milwaukee
country: United States
facility: Pro Spine and Pain
state: Wisconsin
Study officials:
affiliation: SI-BONE
name: Robyn Capobianco, PhD
role: STUDY_DIRECTOR
References: