A Prospective, Randomized, Single-blinded Superiority Study to Evaluate Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Blood Loss
研究概览
简要总结
The purpose of this study is to assess whether the application of bone wax to exposed cancellous bone, after the cemented implants are in place, will provide superior hemostasis in total knee arthroplasty (TKA) patients compared to patients who do not have the bone wax applied. Hemostasis will be assessed by calculating blood loss using the Hb-balance formula.
详细描述
Total joint arthroplasty can result in significant blood loss. Postoperative anemia has been associated with prolonged length of stay and increased hospital costs.1 Minimizing blood loss has led to multiple blood conservation strategies in orthopaedic procedures.
Bone wax is a well-known topical hemostatic agent comprised of a mixture of beeswax, paraffin, and isopropyl palmitate. This inexpensive agent works by sealing the bleeding site and tamponades bleeding from the cancellous bone. Bone wax can be precisely applied evenly and stops bone bleeding immediately upon application.2
The purpose of this study is to assess whether the application of bone wax to exposed cancellous bone, after the cemented implants are in place, will provide superior hemostasis in total knee arthroplasty (TKA) patients compared to patients who do not have the bone wax applied. Hemostasis will be assessed by calculating blood loss using the Hb-balance formula.
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, Care Provider)
盲法说明
Blinding of the principal investigator and operating staff is not possible. However, all attempts will be made to keep this information from the hospital staff caring for the patients in the postoperative period. The patient and the postoperative hospital staff will be blinded to the treatment arm. The OR staff will be trained not to discuss this information with the patient. During the transition of care from the OR to the Post Anesthetic Care Unit (PACU) the treatment arm will not be included in the verbal patient report. The lack of this information is not required to effectively manage the patient in the postoperative period and will not affect patient care. Postoperatively medical care is managed by the hospitalist, medical doctors specializing in the care of hospitalized patients.
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
- •Patients scheduled for primary unilateral total knee arthroplasty
- •Preoperative Hemoglobin >11mg/dL
- •Preoperative platelet count of >150,000
排除标准
- •Patients unable to take aspirin or apixaban for VTE prophylaxis
- •Allergy to any of the ingredients in bone wax (beeswax, paraffin, or isopropyl palmitate)
- •Patients taking clopidogrel (Plavix), ticagrelor (Brilinta), or prasugrel (Effient) or any other antiplatelet medication (except for aspirin 81 mg)
- •Patients unable to get IV Tranexamic Acid for any reason
- •Patients requiring anticoagulant treatment prior to surgery
结局指标
主要结局
Blood Loss
时间窗: Blood loss is measured the morning of postoperative day 1.
To determine if there is a change in blood volume loss between the two study arms.
次要结局
- Knee Society Scoring System(The Knee Society Score was collected within two months prior to the day of surgery and on postoperative day 56 with a collection window of +/- 2 weeks.)
研究者
Eugene Krauss
Director of Orthopaedics, Syosset Hospital, Northwell Health System
Northwell Health