Ultrasound Guided vs Unguided Intra-articular Knee Injections
Accuracy of Ultrasound Guided Versus Unguided Intra-articular Knee Injections in a Difficult to Inject Population
研究概览
详细说明
Patients with BMI > 30 and no clinically detectable knee effusions, with clinical symptoms and radiographic evidence of knee osteoarthritis or inflammatory arthritis, who have been referred for an intraarticular knee injection with corticosteroid will be randomized to either receive ultrasound guidance or not receive ultrasound guidance for their injection. One group will use the ultrasound guidance to position the needle. The other group will use landmarks to position the needle. For both groups, once the proceduralist is comfortable with needle placement for the injection, contrast dye will be injected and fluoroscopy used, to determine if the needle placement is correct. If it is determined the needle placement is not correct, fluoroscopy will be used to reposition it. Once needle placement is determined to be acceptable, the injection will be given. Patient demographics will be collected, along with pain scores preprocedure and two weeks post-procedure.
Subjects are responsible for all clinical costs associated with the injection.
There is no remuneration offered for study participation.
研究类型
阶段
- 第三阶段
联系人和位置
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic in Rochester
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- BMI > 30
- No clinically detectable knee effusion
- Clinical or radiographic evidence of knee osteoarthritis or inflammatory arthritis
- Must be referred to the Pain Clinic for treatment
Exclusion Criteria
- History of surgery on the affected knee
- Evidence of untreated systemic infection or systemic immunocompromise
- Evidence of cutaneous infections near the study knee injection site
- Patients on warfarin with an INR > 3.0
- Patients on oral antiplatelet or anticoagulant medications will be excluded if they have documented evidence of renal insufficiency (GFR < 60)
- History of iodinated contrast allergy or significant reaction to corticosteroids or lidocaine
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Ultrasound Machine Guided Injection
Use of ultrasound machine guidance in needle placement into the knee joint
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Use of ultrasound machine guidance for accurate needle placement into the knee joint
其他名称：
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有源比较器：Unguided Injection
Needle placement performed without ultrasound machine guidance
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Needle placement will take place without ultrasound machine guidance
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Accuracy of the initial needle placement into the knee joint.
大体时间：During the initial needle placement, which can take 1-5 minutes
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The number of participants with accurate initial needle placement into the knee joint
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During the initial needle placement, which can take 1-5 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Improved clinical efficacy of US guided knee injections compared to unguided knee injections
大体时间：30 minutes post injection
|
Comparison of VAS scores 30 minutes after injection between subjects who had ultrasound guided knee injections and those who didn't
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30 minutes post injection
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Detection of knee effusions
大体时间：During procedure, which can take up to 30 minutes to complete
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Comparison of the accuracy of detecting a knee effusion on clinical examination versus ultrasonographically
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During procedure, which can take up to 30 minutes to complete
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合作者和调查者
赞助
调查人员
- 首席研究员：Matthew Pingree, MD、Mayo Clinic
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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