Non-Inferiority Study Comparing Treatment of Primary Knee Osteoarthritis With Intra-Articular Triamcinolone Injections Using 40mg With Landmark Guidance and 20mg With Ultrasound Guidance: The PRECISION-Knee Trial (PRospective Evaluation of the Clinical Impact of Steroid Injection Options iN Knee Osteoarthritis)
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Western Ontario and McMaster Universities Index
研究概览
简要总结
The purpose of this study is to determine whether a lower dose of corticosteroid injection with ultrasound-guidance for the treatment of knee osteoarthritis can be as effective as a higher dose that is landmark-guided. With landmark-guided dosing, it may be reasonable to use a higher amount of corticosteroid in order to ensure a sufficient amount of the medication is administered, however these injections carry the risk of side effects. Alternatively, with the use of ultrasound, it may be reasonable to use less corticosteroid, possibly decreasing the risk of side effects and increasing patient satisfaction.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have already been evaluated within at least one of the 4 study clinics with any of the 3 providers who will be administering the treatment
- •Males or females age 50 and older
- •Already had completion of imaging of the affected knee(s) via radiography and/or MRI
- •Imaging demonstrates osteoarthritis of any severity
- •Diagnosis of primary osteoarthritis of one or both knees
- •One or more symptoms associated with the osteoarthritis of at least one knee
- •Patients able to provide informed consent in English and/or Spanish
排除标准
- •Skin infection at or near area of injection site
- •Recent fracture of the same knee joint within past 6 months
- •Uncontrolled bleeding disorder
- •Intra-articular corticosteroid injection within past 3 months
- •Intra-articular HA injection within the past 3 months
- •Intra-articular PRP injection within the past 3 months
- •Presence of prosthetic knee joint in symptomatic knee
- •Inability to report symptoms due to cognitive impairment
- •Complete inability to ambulate, even with assistive device
- •Any person who is pregnant or less than 1 year post-menopause
研究组 & 干预措施
40mg landmark-guided triamcinolone knee joint injection
干预措施: Triamcinolone knee injection without ultrasound guidance (Drug)
20mg ultrasound-guided triamcinolone knee injection
干预措施: Triamcinolone knee injection with ultrasound guidance (Combination Product)
结局指标
主要结局
Western Ontario and McMaster Universities Index
时间窗: From enrollment to 3 months
Scores are on a scale of 0 through 96, with a higher score indicating a worse function level.
Pain Visual Analog Scale
时间窗: From enrollment to 3 months
scale of 0 through 10, with 10 being the highest pain level.
次要结局
- Immediate change in pVAS (Pain Visual Analog Scale)(From enrollment to immediately after intervention)
研究者
Sosi Dzhugarian
Internal Medicine Physician
Community Memorial Health System