Prospective cohort study to analyse the effect of negative suction drain in Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To assess the effects of surgical drains on postoperative wound complications such as hematoma, infection, and delayed wound healing.
研究概览
简要总结
Total knee arthroplasty (TKA) is a commonly performed procedure for advanced knee osteoarthritis. Postoperative closed suction drains are traditionally used to reduce hematoma formation, swelling, and wound complications. However, recent evidence suggests that drain usage may increase blood loss, transfusion requirements, and delay functional recovery without providing significant clinical benefit.
This prospective randomized controlled trial aims to compare the clinical and functional outcomes of patients undergoing primary total knee arthroplasty with and without postoperative closed suction drainage. A total of 24 patients will be randomly allocated into two groups: Group A (drain group) and Group B (no-drain group). Primary outcomes include postoperative hemoglobin drop and total blood loss. Secondary outcomes include wound complications, postoperative pain, functional outcome assessed using WOMAC score at 1 month, transfusion requirement, and duration of hospital stay.
The findings of this study will help determine whether routine use of postoperative suction drains provides any clinical or functional advantage in patients undergoing primary total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing primary tka with posterior stablised or cruciate sacrificing prosthesis.
排除标准
- •Patients with coagulopathy, inflammatory arthritis, simulataneous bilateral tkr, malignancy, revision tkr and patients on long term anticoagulant therapy.
结局指标
主要结局
To assess the effects of surgical drains on postoperative wound complications such as hematoma, infection, and delayed wound healing.
时间窗: immediate and 1 month
次要结局
- 1. To evaluate the effect of drain usage on postoperative pain and knee swelling.(2. To compare the total blood loss and need for blood transfusions between patients)
研究者
Dr Pradeep Kamboj
Department of Orthopaedics, PGIMS Rohtak