Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty: Prospective Randomized Comparisons With Intraarticular Indwelling
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- blood parameters by which we can estimate blood loss , such as drained blood volume, hemoglobin and hemoglobin drop
研究概览
简要总结
This prospective, randomized trial asked whether subcutaneous indwelling of vacuum drainage has advantages over intraarticular indwelling in terms of blood loss, bleeding related complications, and functional outcomes in primary total knee arthroplasty (TKA). The investigators hypothesized that the subcutaneous indwelling method would reduce blood loss with comparable bleeding-related complications and functional outcomes. The subcutaneous indwelling group demonstrated reduced blood loss with comparable prevalence of bleeding-related complications and functional outcomes. In conclusion, the investigators' study verified the efficacy and absence of risks of subcutaneous indwelling method. So the investigators propose that the subcutaneous indwelling drainage can be a good option to address the problems related to postoperative bleeding after TKA.
详细描述
There are numerous reports in the literature on drainage options after TKA, but there is no consensus. Many studies have shown no apparent advantage of drainage but routine intraarticular indwelling drainage after TKA has been extensively used to avoid complications associated with hematoma formation. It is of interest to determine if it is possible to reduce blood loss while still using drainage. So we came to think about a new and more convenient method-subcutaneous indwelling. Theoretically subcutaneous indwelling method which still has the advantages over the intraarticular indwelling method but is more convenient than drain-clamping method may be a better option. So we hypothesized that subcutaneous indwelling method of vacuum drainage has advantages over the intraarticular indwelling method.
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, Investigator)
入排标准
- 年龄范围
- 54 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary osteoarthritis
- •primary total knee arthroplasty
- •Signed written informed consent
- •Spinal/epidural anesthesia
排除标准
- •Patients with coagulation disorders
- •Revision total knee arthroplasty
- •Simultaneous bilateral total knee arthroplasty
- •Diagnosis other than primary osteoarthritis
- •Patients refusing consents
结局指标
主要结局
blood parameters by which we can estimate blood loss , such as drained blood volume, hemoglobin and hemoglobin drop
时间窗: 24 hours after operation
次要结局
- hypotension episode(during hospital stay)
- transfusion(during hospital stay)
- wound problem(during hospital stay)
- functional outcome (ROM, AKS Knee score, WOMAC score, SF-36 score)(preoperative & postoperative 1 year)