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

Официальное название

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

Обзор

The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain.

Подробное описание

PIERCE is a prospective, multicenter, post-market observational study evaluating the safety, performance, and efficacy of iFuse INTRA Ti.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Composite endpoint of safety and performance [Срок оценки: 6 months.]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07565545 · 303256

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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