NCT05870488进行中（未招募）4 期
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 28
- 主要终点
- Change in SI joint pain measured by numerical rating scale (NRS)
研究概览
简要总结
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (STACI) is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.
详细描述
This trial is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system. The goal of the trial is to demonstrate the effectiveness of the device for its intended use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 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
- •Patient has signed study-specific informed consent form
排除标准
- •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
研究组 & 干预措施
Use of iFuse TORQ for SI Joint Fusion
Other
Participants with SI joint dysfunction are treated with iFuse TORQ.
干预措施: Use of iFuse TORQ (Device)
结局指标
主要结局
Change in SI joint pain measured by numerical rating scale (NRS)
时间窗: At baseline and 6 months
Change in SI joint pain measured by NRS (0- no pain to 10- worst pain imaginable)
次要结局
- Improvement from baseline in quality of life(At baseline, 1-, 3-, 6-, 12-, and 24-months)
- Proportion of subjects with a complication rated as probably or definitely related to the procedure or device.(At baseline, 1-, 3-, 6-, 12-, and 24-months)
- Proportion of iFuse TORQ implants that show evidence of device migration(At baseline and 24 months)
- Improvement from baseline in disability(At baseline, 1-, 3-, 6-, 12-, and 24-months)
- Proportion of iFuse TORQ implants that show breakage(At baseline and 24 months)
- Improvement from baseline in SI joint (SIJ) pain(At baseline, 1-, 3-, 6-, 12-, and 24-months)
- Evidence of bone binding(At baseline and 24 months)
- Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation(At baseline and 24 months)
研究者
研究点 (28)
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