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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Pasteur Lanroze

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pharmacological thromboprophylaxis and elastic compression
  • Pharmacological thromboprophylaxis without elastic compression

Treatment groups

1,274 Participants
are divided into 2 treatment groups

Sponsors and collaborators