NCT07565545尚未招募不适用
Posterior-Inferior Intra-articular Cortical PiERcing Titanium Implant for SaCroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Composite endpoint of safety and performance
研究概览
简要总结
The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain.
详细描述
PIERCE is a prospective, multicenter, post-market observational study evaluating the safety, performance, and efficacy of iFuse INTRA Ti.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •ASA score 4 or
- •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.
研究组 & 干预措施
SIJ Dysfunction treated with INTRA Ti
Patients with sacroiliac joint (SIJ) dysfunction due to various causes refractory to non-surgical management.
干预措施: iFuse INTRA Ti Implant System (Device)
结局指标
主要结局
Composite endpoint of safety and performance
时间窗: 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.
次要结局
- Proportion of Participants with a Serious Adverse Event (SAE)(24 months)
- Proportion of Participants with ≥1 Subsequent Surgical Intervention(s) (SSI)(24 months)
- Proportion of Treated Sides with Radiographic Evidence of Loosening(24 months)
- Proportion of Implants with Radiographic Evidence of Device Migration.(24 months)
- Proportion of Implants with Radiographic Evidence of Device Breakage.(24 months)
- Proportion of Participants with Radiographic Evidence of SI Joint Fusion(12 months)
- Proportion of Participants with Radiographic Evidence of Fusion(24 months)
研究者
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