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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty Complications
• Intervention / Treatment: Procedure: Pharmacological thromboprophylaxis and elastic compression; Procedure: Pharmacological thromboprophylaxis without elastic compression

• Study Type: Interventional
• Enrollment (Estimated): 1274
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Romain Gérard, MD; Phone Number: +33 2 98 28 98 26; Email: dr.romaingerard@protonmail.com

Study Locations

• France
  • Brest, France, 29000
    • Recruiting
    • Clinique Pasteur Lanroze
    • Contact: Anthony Monnier; Phone Number: +33 2 98 31 33 51; Email: amonnier@chp-brest.bzh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Elastic compression	Procedure: Pharmacological thromboprophylaxis and elastic compression; Patients benefit from thromboembolism prevention through pharmacological thromboprophylaxis and elastic restraint after total hip or knee arthroplasty.
Experimental: No elastic compression	Procedure: Pharmacological thromboprophylaxis without elastic compression; Patients benefit from thromboembolism prevention through pharmacological thromboprophylaxis only after total hip or knee arthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of venous thromboembolic events	Evaluation of venous thromboembolic events (symptomatic deep vein thrombosis, fatal or non-fatal pulmonary embolism).	day 1 ; day 21 ; day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life evaluation	Quality of life will be evaluated by EQ-5D-5L questionnaire : 5 questions with a Likert scale from 0 (no symptoms) to 4 (extreme symptoms), with a final result from 0 to 20.	day 1 ; day 21 ; day 90

Collaborators and Investigators

• Sponsor: Clinique Pasteur Lanroze

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: hip replacement surgery; thromboprophylaxis; knee replacement surgery; elastic compression
• Other Study ID Numbers: 2022-04-CPL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No