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

Clinique Pasteur Lanroze

Status

Enrolling

Conditions

Arthroplasty Complications

Treatments

Procedure: Pharmacological thromboprophylaxis and elastic compression

Procedure: Pharmacological thromboprophylaxis without elastic compression

Study type

Interventional

Funder types

Other

Identifiers

NCT06563531

2022-04-CPL

Details and patient eligibility

About

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.

Enrollment

1,274 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)