Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,274
- 试验地点
- 1
- 主要终点
- incidence of venous thromboembolic events
研究概览
简要总结
Venous thrombosis and pulmonary embolism are considered serious and potentially preventable complications of hip and knee replacement surgery. The risks of thrombosis must be weighed against the risks associated with preventive measures, both mechanical and pharmacological. Modern medicine is now questioning the use of elastic restraints in surgery. Several studies have investigated the benefits of using restraints to prevent thromboembolic events. These studies have shown no additional benefit from the use of compression stockings in thromboembolism prevention. To the best of our knowledge, no orthopedic study has investigated the non-inferiority of pharmacological treatment compared with elastic compression devices, specifically in knee and hip surgery. The aim of this multicenter, prospective, randomized study is to investigate whether pharmacological prophylaxis alone is non-inferior to pharmacological and mechanical prophylaxis (using restraints) of peripheral venous thrombosis or pulmonary embolism up to 90 days after prosthetic surgery.
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
- None
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
- •first line and non-traumatic total hip or knee arthroplasty
- •Patient included in an Enhanced Rehabilitation after Surgery (ERS) or "fast-track" protocol, or scheduled as an outpatient.
排除标准
- •Patient requiring long-term anticoagulation for pre-existing co-morbidity
- •Patients with coagulation disorders (hypercoagulability)
- •Patient undergoing thrombogenic pharmacological treatment
- •History of obliterative arteriopathy of the lower limbs
- •Arterial disease
- •Heart failure
- •Chronic bronchopneumopathy
- •Lymphedema
- •Chronic inflammatory disease
- •Permanent wearing of elastic restraints
- •Proximal or distal arterial bypass surgery
- •Creatinine clearance < 15 ml/min
- •Inability to give consent
- •Revision surgery for hip or knee prosthesis
- •Metastatic cancer
- •Life expectancy less than 3 months
- •Allergy to socks or compression stockings
- •Patients presenting one or more exclusion criteria for the fast-track protocol (severe or poorly-balanced associated conditions such as diabetes or immunodepression, inability to contact the doctor or hospital department if necessary, pre-operative ASA score greater than or equal to 4).
- •Adults under guardianship or curatorship
- •Vulnerable persons in accordance with article L1121-6 of the CSP (French Public Health Code)
研究组 & 干预措施
Elastic compression
干预措施: Pharmacological thromboprophylaxis and elastic compression (Procedure)
No elastic compression
干预措施: Pharmacological thromboprophylaxis without elastic compression (Procedure)
结局指标
主要结局
incidence of venous thromboembolic events
时间窗: day 1 ; day 21 ; day 90
Evaluation of venous thromboembolic events (symptomatic deep vein thrombosis, fatal or non-fatal pulmonary embolism).
次要结局
- Quality of life evaluation(day 1 ; day 21 ; day 90)