Degenerative Sacroiliitis, Sacroiliac Disorder, Sacroiliac Joint Disruption, Sacroiliac Joint Dysfunction, Sacro Iliac Joint Pain, Sacro-iliac Joints
Conditions
Keywords
sacroiliac fusion, SI-BONE, INTRA Ti
Brief summary
The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain.
Detailed description
PIERCE is a prospective, multicenter, post-market observational study evaluating the safety, performance, and efficacy of iFuse INTRA Ti.
Interventions
DEVICEiFuse INTRA Ti Implant System
FDA-cleared implant used for fusion of the sacroiliac joint (SIJ) for SIJ dysfunction, that is a direct result of SIJ disruption and degenerative sacroiliitis.
Sponsors
SI-BONE, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 21 years. 2. Patient has chronic lower back pain (≥6 months) refractory to non-surgical care. 3. Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or SIJ disruption) and scheduled to be treated with INTRA Ti. 4. Patient has SIJ pain of at least 5 on a 0-10 numeric rating scale (NRS) prior to procedure. 5. Participant 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. Current diagnosis of cluneal neuralgia. 5. Previous SIJ implant placement, including allograft, on the treated (index) side. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of safety and performance | 6 months. | The participant is considered a success if all the following criteria are met: * A ≥ 2 point improvement from baseline in SIJ pain on the target side. * Absence of device-related SAE. * Absence of SSI at index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with a Serious Adverse Event (SAE) | 24 months | Proportion of participants with a serious adverse event classified as probably or definitely related to the study device or procedure |
| Proportion of Participants with ≥1 Subsequent Surgical Intervention(s) (SSI) | 24 months | Proportion of participants undergoing one or more SSI related to the index procedure. |
| Proportion of Treated Sides with Radiographic Evidence of Loosening | 24 months | Proportion of treated sides showing signs of loosening of INTRA Ti, as evidenced by both radiolucent areas around implant plus bony reaction ("rind") near implant. |
| Proportion of Implants with Radiographic Evidence of Device Migration. | 24 months | Proportion of INTRA Ti implants that show evidence of device migration. |
| Proportion of Implants with Radiographic Evidence of Device Breakage. | 24 months | Proportion of INTRA Ti implants that show breakage. |
| Proportion of Participants with Radiographic Evidence of Fusion | 24 months | Bony apposition to the implant at 12 months as evaluated by pelvic CT |
Contacts
CONTACTDirector of Clinical Affairs
STUDY_DIRECTORStacie Tran, MPH
SI-BONE
Outcome results
None listed