NCT06909292已完成不适用
A Post-market, Multicenter, Prospective, Clinical Study to Evaluate the Nevro1 Sacroiliac (SI) Transfixing and Fusion System for the Treatment of Sacroiliac Joint Dysfunction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nevro Corp
- 入组人数
- 180
- 试验地点
- 10
- 主要终点
- Composite Pain Relief and Safety Responder
研究概览
简要总结
The goal of this observational study is to learn if Nevro1 Sacroiliac Transfixing and Fusion System can treat sacroiliac joint dysfunction in males or females over 21. The main questions it aims to answer is what percentage of patients have clinically important pain relief with no adverse events, and what proportion of patients have fusion of the sacroiliac joint at 1 year and 2 years.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure-related care, and all coverage criteria required by insurer are met, which may include but are not limited to:
- •Has had low back and/or buttock pain for at least 6 months that is inadequately responsive to non-surgical care
- •Has a positive Fortin's test
- •Has a diagnosis of SIJ dysfunction (degenerative sacroiliitis or SI disruption) with pain elicited on at least 3 of 5 provocative tests (FABER, Gaenslen, Distraction, Thigh Thrust, Compression).
- •At least 75% reduction in pain for the expected duration of two anesthetics (on separate visits each with a different duration of action), and the ability to perform previously painful maneuvers, following an image-guided, contrast-enhanced intra-articular (diagnostic) SIJ injection
- •A trial of at least one therapeutic intra-articular SIJ injection (i.e. corticosteroid injection)
- •Has an ODI score ≥30% at enrollment
- •Has a SI joint pain score of at least 5 out of 10 on numerical rating scale at enrollment.
- •Be at least 21 years of age at enrollment
- •The patient's physician has decided that the best treatment for the patient's SIJ dysfunction is the Nevro1 SI Fixation System, and the patient has agreed to the treatment
- •Be willing and capable of giving written informed consent
- •Be mentally and physically able to comply with study-related requirements and procedures and attend all scheduled visits
排除标准
- •Has current severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar radicular pain, and lumbar vertebral body fracture
- •Has SIJ pain secondary to inflammatory conditions or other known sacroiliac pathology such as: Sacral dysplasia, inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondylo-arthropathy), tumor, infection, acute fracture, and crystal arthropathy
- •Has had a previous SIJ implant placement, including an allograft
- •Has had an injection with corticosteroid into the index SIJ within the last 30 days
- •Has had a sacral radiofrequency ablation within the last 6 months
- •Has a history of recent (<1 year) major trauma to pelvis
- •Has previously diagnosed or suspected severe osteoporosis (defined as prior T-score < -2.5 or history of osteoporotic fracture)
- •Has a chronic rheumatologic condition (e.g., rheumatoid arthritis)
- •Has a known allergy to titanium or titanium alloys
- •Has a current local or systemic infection that raises the risk of surgery
- •Is currently receiving or seeking short- or long-term worker's compensation related to the SI joint or low back pain, is currently receiving disability remuneration related to SI joint or low back pain, and/or is currently involved in injury litigation related to the SI joint or low back pain
- •Is participating in an investigational study or has been involved in an investigational study within 3 months prior to enrollment
- •Has any condition or anatomy that makes treatment with the Nevro1 SI Fixation System infeasible
- •Is taking a medication known to have detrimental effects on bone quality and soft tissue healing
- •Has a prominent neurologic condition that would interfere with physical therapy
- •Be pregnant or plan on becoming pregnant in the next two years.
- •Has a medical condition or pain in other area(s), not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
结局指标
主要结局
Composite Pain Relief and Safety Responder
时间窗: 6 months
The proportion of patient meeting the following criteria: * NRS score for SIJ pain reduced by at least 2 points from baseline. * Absence of implant-related serious adverse events (SAEs). * Absence of neurologic worsening related to the lumbosacral nerve roots. * Absence of reoperation (removal, revision reoperation or supplemental fixation) for SIJ pain.
次要结局
- Change in Disability(6 months)
- Patient Global Impression of Change (PGIC)(6 months)
- Physical and Mental Health Summary (PROMIS-29)(6 months)
- Change in Quality of Life(6 months)
- Change in Sleep Disturbance Due to Pain(6 months)
- Timed "Up and Go" Performance test (TUG)(6 months)
研究者
研究点 (10)
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