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NCT Number: NCT06563531

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.

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Key information

Conditions

Arthroplasty Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pharmacological thromboprophylaxis and elastic compression

Procedure

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

Pharmacological thromboprophylaxis without elastic compression

Procedure

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

Primary outcomes

  1. incidence of venous thromboembolic events

    Time frame: day 1 ; day 21 ; day 90

    Evaluation of venous thromboembolic events (symptomatic deep vein thrombosis, fatal or non-fatal pulmonary embolism).

Secondary outcomes

  1. Quality of life evaluation

    Time frame: day 1 ; day 21 ; day 90

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Romain Gérard, MD

CONTACT

[email protected]

+33 2 98 28 98 26

Sponsors and collaborators

Lead sponsor

Clinique Pasteur Lanroze

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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