Clinical Trial

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

Recruiting
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-08-19; most recent amendment 2026-03-31.
Status change: Not Yet Recruiting → Recruiting 2024-11-18
Trial Details
NCT Number NCT06563531
Lead Sponsor Clinique Pasteur Lanroze
Conditions Arthroplasty Complications
Enrollment 1,274 participants
Start Date 2024-11-15
Primary Completion 2027-06-15 (estimated)
Study Completion 2027-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-06