iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
Sacroiliac Joint Dysfunction, Sacroiliac; Fusion, Sacroiliac Disorder
About this trial
This is an interventional treatment trial for Sacroiliac Joint Dysfunction
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. Known or suspected active drug or alcohol abuse, including opioids Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation Currently participating in another interventional clinical trial
Sites / Locations
- Total Spine InstituteRecruiting
- Napa Valley OrthopaedicsRecruiting
- Source HealthcareRecruiting
- Ascentist HealthcareRecruiting
- University of KentuckyRecruiting
- Clearway PainRecruiting
- iSpineRecruiting
- St Louis Pain ConsultantsRecruiting
- Nevada Advanced PainRecruiting
- Clinical InvestigationsRecruiting
- Neurological Associates of LancasterRecruiting
- Northwest Pain CareRecruiting
Arms of the Study
Arm 1
Other
Use of iFuse TORQ for SI Joint Fusion
Participants with SI joint dysfunction are treated with iFuse TORQ.