Not yet recruiting NCT07565545

Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes

— Observational Sacro Iliac Joint Pain Sacro-iliac Joints Sacroiliac Disorder Sacroiliac Joint Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: iFuse INTRA Ti Implant System.
Who it may be relevant to: Registry conditions: Sacro Iliac Joint Pain, Sacro-iliac Joints, Sacroiliac Disorder, Sacroiliac Joint Dysfunction. Basic parameters: from 21 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Posterior-Inferior Intra-articular Cortical PiERcing Titanium Implant for SaCroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes

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.

Device iFuse 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.

Secondary outcome measures (6)

Proportion of Participants with a Serious Adverse Event (SAE) [Time frame: 24 months]
Proportion of Participants with ≥1 Subsequent Surgical Intervention(s) (SSI) [Time frame: 24 months]
Proportion of Treated Sides with Radiographic Evidence of Loosening [Time frame: 24 months]
Proportion of Implants with Radiographic Evidence of Device Migration. [Time frame: 24 months]
Proportion of Implants with Radiographic Evidence of Device Breakage. [Time frame: 24 months]
Proportion of Participants with Radiographic Evidence of Fusion [Time frame: 24 months]

Age > 21 years.
Patient has chronic lower back pain (≥6 months) refractory to non-surgical care.
Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or SIJ disruption) and scheduled to be treated with INTRA Ti.
Patient has SIJ pain of at least 5 on a 0-10 numeric rating scale (NRS) prior to procedure.
Participant has signed study-specific informed consent form.

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.
Current diagnosis of cluneal neuralgia.
Previous SIJ implant placement, including allograft, on the treated (index) side.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Center list to be confirmed — check the primary protocol.

NCT: NCT07565545 · 303256