Efficacy of Tranexamic Acid in the Reduction of Postoperative Complications Following Medial Opening Wedge High Tibial Osteotomy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Haemoglobin (g/L) value
研究概览
简要总结
The purpose of the study is to assess the effect of Tranexamic acid (TXa), a commonly used medication to prevent bleeding, in reducing blood loss during High Tibial Osteotomy (HTO). HTO is a common procedure aimed at realigning patients that are bow-legged, in an attempt to reduce pain associated with osteoarthritis of the knee, and to prevent its progression. A secondary aim is to assess the effect of TXa in preventing side-effects of surgery related to the healing of surgical wound.
详细描述
Medial opening wedge high tibial osteotomy (MOW HTO) is an effective treatment of varus malalignment with associated medial compartment osteoarthritis, medial compartment osteochondral defect, and instability (1-3). Although this technique was developed to limit complications relative to its counterpart, the lateral closing wedge high tibial osteotomy, adverse events occur in up to 55% of cases. Martin et al stratified these adverse events and described the overall complication rate requiring further surgical management or long-term medical care to be 7%. Their stratification included 1) adverse events requiring no additional treatment such as delayed wound healing (6%) and hematoma (3%), 2) adverse events requiring extended non-operative management such as cellulitis (10%) and deep vein thrombosis (1%), and 3) adverse events requiring additional surgery such as deep infection (2%)(3).
There is emerging evidence that Tranexamic Acid (TEA) can safely and effectively decrease blood loss in patients undergoing HTO. Whilst rare, this may reduce the need for post-operative blood transfusions. There is also emerging evidence that TEA has a role in infection prevention in open reduction and internal fixation of traumatic fractures, as well as a decreased periprosthetic infection risk in hip and knee arthroplasty (4,5). This is thought to occur by indirect mechanisms such as the prevention of haematoma, but also direct mechanism through prevention of biofilm formation. There has not been a high-quality randomised controlled trial to demonstrate this effect however.
The Patient Observer Scar Assessment Scale (POSAS) is a widely used and validated clinical assessment tool that measures differences in wound-related outcomes(6). It is a sensitive measure of subtle changes in scar and wound healing due to treatment effect and can be used in addition to binary wound complication outcomes such as cellulitis, haematoma, purulence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mechanical varus alignment and knee OA according to Rheumatology classification criteria (Altman, 1986), with the greatest severity in the medial compartment of the tibiofemoral joint
- •Undergoing Medial opening wedge high tibial osteotomy by or under guidance from Fellowship Trained Sports Orthopaedic Surgeons
排除标准
- •Allergy to tranexamic acid. Acquired disturbances of colour vision, preoperative use of anticoagulants within 5 days of surgery, coagulopathy as described by pre-op platelet count of <150,000/mm3, pregnancy, breast feeding (From Wong, 2010)
- •Inflammatory or infectious arthritis. Major neurologic deficit. (From Birmingham, 2009)
- •Prior history of venous thrombotic event being treated with life-long anticoagulation.
- •Patients known to have congenital thrombophilia, and patients who have had a known venous thromboembolic event within 1 year preceding surgery. (From Ralley 2010)
- •Patients taking hormonal contraceptives, Factor IX complex concentrates, anti-inhibitor coagulant concentrates, thrombin, batroxobin or haemocoagulase. These medications could potentially increase thrombotic risk if taken concomitantly with tranexamic acid (McCormack, 2012)
研究组 & 干预措施
Standard of Care
Patients will undergo routine medial opening wedge high tibial osteotomy by one of five fellowship trained orthopaedic surgeons.
干预措施: Routine medial opening wedge high tibial osteotomy (Procedure)
SOC + Tranexamic Acid
Patients will undergo routine medial opening wedge high tibial osteotomy by one of five fellowship trained orthopaedic surgeons with the addition of administration of 20 mg/kg intravenous Tranexamic Acid at the beginning of the surgical procedure/surgical pause.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Haemoglobin (g/L) value
时间窗: Change between the patient's pre-operative blood draw (day of surgery) and that collected on day 1 post-operatively.
To prospectively evaluate the effect of tranexamic acid in reducing blood loss during High Tibial Osteotomy
次要结局
- Knee injury and Osteoarthritis Outcome Score (KOOS)(Pre-op (up to 6 months before surgery) , 2 & 6 weeks post -op, 3 & 6 months post-op)
- Patient and Observer Scar Assessment Scale (POSAS)(2 & 6 weeks, 3 & 6 months post-op)
- Measurement of Calf Circumference(pre-operatively (up to 6 months prior to surgery), post-op 2 & 6 weeks)
- Visual Analog Pain Scale(2 & 6 weeks post-op)