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

NCT06563531 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1274

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Arthroplasty Complications

Interventions

PROCEDURE

Pharmacological thromboprophylaxis and elastic compression

Patients benefit from thromboembolism prevention through pharmacological thromboprophylaxis and elastic restraint after total hip or knee arthroplasty.

PROCEDURE

Pharmacological thromboprophylaxis without elastic compression

Patients benefit from thromboembolism prevention through pharmacological thromboprophylaxis only after total hip or knee arthroplasty.

Sponsors & Collaborators

  • Clinique Pasteur Lanroze

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2027-06-15
Completion
2027-07-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06563531 on ClinicalTrials.gov