Investigating the Use of a Cryopneumatic Therapy Device in Primary Total Knee Arthroplasty Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 224
- 试验地点
- 22
- 主要终点
- Physical function performance
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of a device that delivers cold and intermittent compression as compared to ice and compressive wraps on patients who have undergone knee replacement.
详细描述
The use of cryotherapy with compression for orthopedic postoperative recovery has not been fully investigated. A new device has been developed that combines cold and intermittent pneumatic compression in a single system. A well-controlled clinical study evaluating the clinical effectiveness of cryotherapy with compression in an orthopedic postoperative application is the subject of this protocol. Patients diagnosed with osteoarthritis of the knee and scheduled for primary total knee arthroplasty procedure will be invited to participate in this study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 but no more than 85 years of age
- •Body Mass Index not greater than 40
- •Diagnosis of osteoarthritis of the knee
- •Medically cleared for total knee replacement surgery
- •Physically and mentally able and willing to participate in and follow the study protocol and schedule
- •Able and willing to have all postoperative physical therapy visits in a physical therapy clinic associated with the research site
- •Signed informed consent document for the study
排除标准
- •Rheumatoid arthritis
- •Severe pitting edema in the ipsilateral limb
- •History of thrombophlebitis in lower extremities
- •An active systemic disease such as AIDS, HIV, hepatitis, etc.
- •Is immunologically suppressed or has received or is receiving steroids at any dose daily for more than one month within the last 12 months
- •Is pregnant or planning to become pregnant during the study period
- •Any condition that would contraindicate using the Game Ready
- •Currently enrolled in another clinical trial that could affect outcome of this study
- •Previously enrolled in this study
研究组 & 干预措施
B
干预措施: Ice with compressive bandages (Other)
A
干预措施: Game Ready Injury Treatment System (CoolSystems Inc.) (Device)
结局指标
主要结局
Physical function performance
时间窗: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
Time to reach defined physical therapy milestones
时间窗: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative
次要结局
未报告次要终点