Thigh Pain After Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Outcomes Survey (KOOS)
研究概览
简要总结
The purpose of this research study is to evaluate the cause of thigh pain after knee replacement. Different surgical techniques will be used to help determine the cause of thigh pain, and all surgical techniques are accepted and produce good clinical results.
详细描述
This research study will be a randomized study in which patients volunteer participate. "Randomized" means the patients who received the new treatment are chosen at random, similar to flipping a coin. Several factors have been identified as possible sources of thigh pain after surgery: use of a tourniquet around the thigh to control bleeding during surgery; use of an intramedullary rod during surgery or quadriceps muscle strain. Participants will be randomized into surgical groups that use/do not use a tourniquet and use/do not use intramedullary rod during surgery. A subset of participants in all surgical groups will have a MRI to look for quadriceps muscle strain.
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
- •Subjects undergoing total knee arthroplasty for osteoarthritis
- •Adult patients (age 18 years or older)
- •Written informed consent
- •Ability to speak, read and write English or Spanish
排除标准
- •Inability to speak, read and write English or Spanish
- •Evidence of malignant disorder/neoplasm in past 60 months
- •Contraindication for removal of infrapatellar fat pad
- •History of smoking and not committed to give up
- •Chronic skin conditions
- •Connective, metabolic or skin disease
- •Evidence of active infection
- •Pregnancy or lactating for female subjects
- •Current corticosteroid use
- •Immunosuppressive medication
- •Renal failure (creatine > 1.8 mg/dL)
- •Hepatic failure (AST, ALT > 2x normal values; bilirubin > 2 mg/dL)
- •Inflammatory joint diseases of the knee that indicate additional, conflating therapies
- •Joint infection within the past 6 months
- •No prisoners or mentally disabled persons
- •No Workers' Compensation cases
结局指标
主要结局
Knee Injury and Osteoarthritis Outcomes Survey (KOOS)
时间窗: up to 3 months
Survey
次要结局
- Number of Patients with Adverse Events as a Measure of Safety(up to 3 months)
- Pain Scores on Numerical Rating Scale(up to 3 months)
- Knee swelling(up to 3 months)
- Knee Range of Motion(up to 3 months)