Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?

Обзор

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.

Вмешательства

• Процедура Pharmacological thromboprophylaxis and elastic compression
  Patients benefit from thromboembolism prevention through pharmacological thromboprophylaxis and elastic restraint after total hip or knee arthroplasty.
• Процедура Pharmacological thromboprophylaxis without elastic compression
  Patients benefit from thromboembolism prevention through pharmacological thromboprophylaxis only after total hip or knee arthroplasty.

Первичные конечные точки

• incidence of venous thromboembolic events [Срок оценки: day 1 ; day 21 ; day 90]

Вторичные конечные точки (1)

• Quality of life evaluation [Срок оценки: day 1 ; day 21 ; day 90]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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
• Obesity
• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Clinique Pasteur Lanroze — Brest

Идентификаторы

NCT: NCT06563531 · 2022-04-CPL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗