NCT01640353已完成不适用
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 26
- 主要终点
- Subject Success
研究概览
简要总结
The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is a medical device that is surgically implanted into the sacroiliac (SI) joint during a minimally invasive surgical procedure (one that uses a smaller incision and less damage to the skin and other tissues than standard surgery). The purpose of implanting the device is to stabilize and fuse the SI joint.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-70 at time of screening
- •Patient has lower back pain for >6 months inadequately responsive to conservative care
- •Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:
- •Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and
- •Patient has at least 3 of 5 physical examination maneuvers specific for the SI joint (see Table 3), and
- •Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50% after injection of local anesthetic into affected SI joint(s) (see Section 3.6.4), and
- •One or more of the following:
- •i. SI joint disruption:
- •Asymmetric SI joint widening on X-ray or CT scan
- •Leakage of contrast on diagnostic arthrography
- •ii. Degenerative sacroiliitis:
- •Radiographic evidence of SI joint degeneration, including sclerosis,osteophytes, subchondral cysts, or vacuum phenomenon on CT or plain film, or
- •Due to prior lumbosacral spine fusion
- •Baseline Oswestry Disability Index (ODI) score of at least 30%
- •Baseline SI joint pain score of at least 50 on 0-100 mm visual analog scale
- •Patient has signed study-specific informed consent form
- •Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
排除标准
- •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:
- •Sacral dysplasia
- •Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)
- •Acute fracture
- •Crystal arthropathy
- •History of recent (< 1 year) major trauma to pelvis
- •Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture).
- •Osteomalacia or other metabolic bone disease
- •Chronic rheumatologic condition (e.g., rheumatoid arthritis)
- •Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
- •Chondropathy
- •Known allergy to titanium or titanium alloys
- •Use of medications known to have detrimental effects on bone quality and soft-tissue healing
- •Prominent neurologic condition that would interfere with physical therapy
- •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
- •Patient is a prisoner or a ward of the state.
- •Known or suspected drug or alcohol abuse
- •Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
- •Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation
结局指标
主要结局
Subject Success
时间窗: Baseline and 6 months
Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention.
次要结局
- Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)(24 months)
- Change in Back Dysfunction(24 months)
- Change in Quality of Life(Baseline and 24 months)
- Ambulatory Status(24 months)
- Work Status(Basline, 24 months)
- Serious Adverse Events(Procedure, discharge, 1,3,6,12,18 and 24 months)
研究者
研究点 (26)
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