Clinical trial NCT06563531: Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?
Official title: Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthroplasty Complications
Keywords: hip replacement surgery
knee replacement surgery
thromboprophylaxis
elastic compression
Lead sponsor: Clinique Pasteur Lanroze
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 1274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: incidence of venous thromboembolic events
timeFrame: day 1 ; day 21 ; day 90
Secondary outcomes:
measure: Quality of life evaluation
timeFrame: day 1 ; day 21 ; day 90
Other outcomes:
Locations:
city: Brest
country: France
facility: Clinique Pasteur Lanroze
Study officials:
References: