Investigating the necessity of elastic restraints after hip and knee surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate whether pharmacological prophylaxis alone is as effective as a combination of pharmacological and mechanical prophylaxis (using elastic restraints) in preventing venous thrombosis after hip and knee arthroplasty. The study will involve a multicenter, prospective, randomized design, focusing on patients undergoing first-line, non-traumatic total hip or knee replacements as part of an Enhanced Rehabilitation after Surgery protocol. By comparing these two approaches, the trial seeks to determine the non-inferiority of pharmacological treatment without the use of elastic compression devices. The findings could provide valuable insights into optimizing postoperative care and reducing unnecessary interventions.

Why it matters

Who can join: the full rules

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)

Where it's running

• Clinique Pasteur Lanroze
  Brest, France Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.