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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2026-07-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthroplasty Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Elastic compression

Group Type ACTIVE_COMPARATOR

Pharmacological thromboprophylaxis and elastic compression

Intervention Type PROCEDURE

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

No elastic compression

Group Type EXPERIMENTAL

Pharmacological thromboprophylaxis without elastic compression

Intervention Type PROCEDURE

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

Interventions

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Pharmacological thromboprophylaxis and elastic compression

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

Intervention Type PROCEDURE

Pharmacological thromboprophylaxis without elastic compression

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
* Adults under guardianship or curatorship
* Vulnerable persons in accordance with article L1121-6 of the CSP (French Public Health Code)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No