PET MRI for Evaluation of Knee Osteoarthritis in Patients With Bilateral Knee OA
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- correlation between SUV to clinical evaluation
研究概览
简要总结
Osteoarthritis (Osteoarthritis) of the knee is a high prevalence in the population of people aged 60 years and over, when in some cases does not cause any discomfort or pain, and therefore not diagnosed. In addition, Radio graphic findings of the knee not fully compatible with the patient's symptoms, which resulted in errors in the interpretation and diagnosis.
In this study, patients who suffer from two knees or unilateral pain, will take part. Participants will undergo a clinical examination, including evaluation of symptoms by an orthopedist and an X-ray imaging, which are part of the currently accepted medical diagnosis.
Patients will perform PET-MRI test in order to assess whether PET MRI is a more efficient tool for active knee osteoarthritis diagnosis.
详细描述
Knee Osteoarthritis has high incidence in the population over 60 years reaching a rate of 10% in several studies. However, not all arthritic knee joints are actively causing patient discomfort or pain. There is only a limited correlation between patient radio graphs and symptoms leading to high rates of false positive and false negative of knee OA. Consequently, patients may have bilateral knee arthritis when the more arthritic knee per x-ray is less symptomatic. On the other hand knee MRI and bone scan maybe oversensitive for diagnosis knee arthritis with a high rate of false positive.
The purpose of this study is to examine the value of PET MRI as a tool for accurate diagnosis of active knee osteoarthritis.
The hypothesis is that using PET MRI of both knees may correlate better than radio graphs or MRI by themselves to patient symptoms .
The study will consist of 150 patients with bilateral or unilateral knee pain with one of the knees having more symptoms than the other. The study physicians who perform the PET MRI will be blinded to the patient symptoms and will record their findings and which knee is more symptomatic and along which pattern
Enrollment:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients that are sent for knee MRI
- •Patients over the age of 50 years old
- •All patients will sign an informed consent for the study prior to the PET MRI
- •Unilateral or Bilateral knee pain
- •All patients were ambulatory pre-operatively, using no more then a single cane
- •All patients had prior Weight Bearing AP x-rays and Lateral Radiogrphs
排除标准
- •Non ambulatory patients
- •History of knee arthroscopy or other surgery 1 year before the MRI
- •Bone scan performed in the past 3 months prior to the PET MRI
- •Clastrophobia
结局指标
主要结局
correlation between SUV to clinical evaluation
时间窗: 3 months - 1 year
correlation between SUV PET vs. WOMAC and VAS pain scores.
次要结局
未报告次要终点
研究者
david groshar
Pro. David Groshar
Assuta Medical Center