Intermittent Pneumatic Compression Effects on Venous Thromboembolism Incidence and Healing of Achilles Tendon Rupture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Venous Thromboembolic Events (VTE)
研究概览
简要总结
This prospective randomized study aims to determine whether intermittent pneumatic compression (IPC), 75 patients, beneath functional bracing compared to treatment-as-usual in plaster cast, 75 patients, can reduce the Venous Thromboembolism (VTE) incidence and promote healing of sutured acute Achilles tendon ruptures.
At two weeks post surgery, the IPC intervention will be ended and both patient groups will be immobilized in an orthosis until follow-up at six weeks.
The endpoint of the first part of the study is VTE events. The primary outcome will be the DVT-incidence at two weeks, assessed using screening compression duplex ultrasound (CDU) by two ultrasonographers masked to the treatment allocation. Secondary outcome will be the DVT-incidence at 6 weeks.
1) Deep Vein Thrombosis (DVT) detected by CDU , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography.
The endpoint of the second part of the study is tendon healing quantified at 2 weeks by microdialysis followed by quantification of markers for tendon repair.
The endpoint of the third part of the study is the functional outcome of the patients at one year post-operatively using four reliable and valid scores, i.e. the Achilles tendon Total Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and EuroQol Group's questionnaire (EQ-5D) as well as the validated heel-rise test.
详细描述
The incidence of DVT after Achilles tendon rupture is as high as 30-40% and patients exhibit a prolonged healing process with variable outcome. Moreover, it has been demonstrated that low molecular weight heparin had no effect on preventing DVT after Achilles tendon surgery. Whether intermittent pneumatic compression (IPC) can prevent DVTs and improve healing after Achilles tendon rupture has to our knowledge not been tested before.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Achilles tendon rupture operated on within 96 hours of diagnose.
排除标准
- •Inability or refusal to give informed consent for participation in the study
- •Ongoing treatment with anticoagulant therapy
- •Inability to comply with the study instructions
- •Known kidney disorder
- •Heart failure with pitting oedema
- •Thrombophlebitis
- •Recent thromboembolic event (during the preceding 3 months)
- •Recent surgery (during the preceding month)
- •Presence of known malignancy
- •Current bleeding disorder
结局指标
主要结局
Venous Thromboembolic Events (VTE)
时间窗: 2 weeks
At 2 weeks postoperatively the number of participants with VTE events will be assessed by: 1\) DVT detected by compression duplex ultrasound (CDU) , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography.
次要结局
- Functional Outcome - Muscular Endurance Tests (Heel-rise)(one year)
- Patient-reported Outcome(One year)
- Time From Injury to Surgery(1 year)
- Microdialysis(2 weeks)
- Venous Thromboembolic Events (VTE)(6 weeks)
研究者
Paul Ackermann
MD, PhD
Karolinska University Hospital