Effect of Timing of Hemovac Drain Removal on Early Outcomes After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Postoperative Drain Output
研究概览
简要总结
This study aims to evaluate whether the timing of Hemovac drain removal affects early clinical outcomes after primary total knee arthroplasty (TKA). Hemovac drains are commonly used after TKA to reduce postoperative bleeding and swelling; however, the optimal timing for drain removal remains controversial.
In this prospective observational cohort study, patients undergoing primary TKA for knee osteoarthritis will be divided into two groups according to routine clinical practice: those whose drain is removed before the first postoperative rehabilitation session and those whose drain is removed after the first rehabilitation session.
The primary outcomes include the rate of postoperative hemarthrosis, early postoperative complications, and length of hospital stay. Secondary outcomes include postoperative pain levels and functional outcomes. The results of this study may help optimize postoperative management strategies following total knee arthroplasty.
详细描述
Total knee arthroplasty (TKA) is a widely performed surgical procedure for the treatment of advanced knee osteoarthritis. Postoperative management often includes the use of closed suction drains, such as Hemovac systems, to reduce hematoma formation and wound complications. However, the necessity and optimal timing of drain removal remain subjects of debate.
This prospective observational cohort study is designed to compare early clinical outcomes associated with two different timings of Hemovac drain removal following primary TKA. Patients who undergo primary TKA at a single tertiary care center will be enrolled prospectively. According to routine postoperative practice, patients will be allocated into two groups: drain removal before the first postoperative rehabilitation session or drain removal after completion of the first rehabilitation session.
All patients will receive standardized surgical techniques, anesthesia protocols, postoperative care, and rehabilitation programs. Data will be collected prospectively. Primary outcomes include postoperative hemarthrosis, early postoperative complications, and length of hospital stay. Secondary outcomes include postoperative pain intensity and functional outcome measures.
This study aims to provide evidence to guide clinical decision-making regarding postoperative drain management in patients undergoing total knee arthroplasty.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 aged 18 years or older
- •Diagnosis of knee osteoarthritis
- •Undergoing primary total knee arthroplasty
- •Provided written informed consent to participate in the study
排除标准
- •Revision total knee arthroplasty
- •History of inflammatory arthritis
- •Known bleeding disorders or coagulopathy
- •Active infection or periprosthetic joint infection
- •Incomplete clinical data or loss to follow-up
研究组 & 干预措施
Early Drain Removal (Goup 1)
Patients whose Hemovac drain is removed before the first postoperative rehabilitation session as part of routine clinical practice.
Late Drain Removal (Group 2)
Patients whose Hemovac drain is removed after completion of the first postoperative rehabilitation session as part of routine clinical practice.
结局指标
主要结局
Postoperative Drain Output
时间窗: Postoperative days 0-3
Total postoperative Hemovac drain output measured in milliliters following primary total knee arthroplasty.
次要结局
- Length of Hospital Stay(Postoperative days 0-discharge)
- Postoperative Hemoglobin Change(Postoperative first 24-48 hours)
- Knee Society Score (KSS)(Postoperative 1 month)
- Postoperative Pain Intensity(Postoperative 1 month)
研究者
Şahan Güven
Medical Doctor, specialist
Ankara City Hospital Bilkent