Practical Indications for Sonography in Musculoskeletal Medicine-Knee Joint Injections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Number of Participants With Successful Knee Injection
研究概览
简要总结
This study will compare the accuracy and patient reported outcomes between four different techniques used to perform a knee injection.
详细描述
This study will compare the accuracy and patient-oriented outcomes between various techniques for intra-articular knee injections. Historically, a joint line (intercondylar) technique of injection at the medial or lateral joint line, reliant solely upon clinical palpation, has been the most popular approach among primary care and orthopedic providers. Newer approaches, making use of ultrasound visualization to accomplish access to the intercondylar recess and the anterolateral suprapatellar pouch, have gained in popularity. Because of uncertain accuracy with the traditional approach, this study is designed to determine if sonographic visualization combined with either of these two newer techniques improves accuracy and affects patient-oriented outcomes.
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)
盲法说明
Patients will be blindfolded for the duration of their procedure. Investigator will always place ultrasound probe on patient's knee regardless of group assignment to eliminate bias. To further enhance blinding, the ultrasound screen will placed on freeze for the patients randomized into the groups without ultrasound guidance. Radiologist will be blinded to patient's group assignment.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 to 90
- •Clinician determined need for intra-articular knee injection
- •Radiograph confirmed grade 1-4 Kellgren Lawrence osteoarthritis scale
排除标准
- •Allergy to contrast dye, shellfish
- •Allergy to egg product or hyaluronate
- •Allergy to lidocaine
- •Localized skin infection at planned site of injection
- •Inability to complete follow-up phone call three months following the injection
- •Viscosupplementation injection within 6 months of the current evaluation
结局指标
主要结局
Number of Participants With Successful Knee Injection
时间窗: Procedure visit 3 (3-4 weeks after 1st injection)
To assess presence or absence of contrast medium within the target knee joint as determined by a blinded radiologist. If contrast medium could be observed in the joint then the injection was considered a success.
次要结局
- Procedural Satisfaction Score at 3 Months Post Injection(3 month follow-up appointment following 3rd injection)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score(Pre-Injection and 3 month follow-up appointment following 3rd injection)