Accuracy of Ultrasound Guided Versus Unguided Intra-articular Knee Injections in a Difficult to Inject Population
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 主要终点
- Accuracy of the initial needle placement into the knee joint.
研究概览
简要总结
To determine the accuracy of unguided versus ultrasound (US) guided knee joint injections in obese patients with no clinically detectable effusion.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ultrasound Machine Guided Injection
Use of ultrasound machine guidance in needle placement into the knee joint
干预措施: Ultrasound machine (Device)
Unguided Injection
Needle placement performed without ultrasound machine guidance
干预措施: Unguided injection (Device)
结局指标
主要结局
Accuracy of the initial needle placement into the knee joint.
时间窗: During the initial needle placement, which can take 1-5 minutes
The number of participants with accurate initial needle placement into the knee joint
次要结局
- Improved clinical efficacy of US guided knee injections compared to unguided knee injections(30 minutes post injection)
研究者
Matthew Pingree
Assistant Professor of Physical Medicine and Rehabilitation
Mayo Clinic