Arthroplasty Complications
Conditions
Keywords
hip replacement surgery, knee replacement surgery, thromboprophylaxis, elastic compression
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.
Interventions
PROCEDUREPharmacological thromboprophylaxis and elastic compression
Patients benefit from thromboembolism prevention through pharmacological thromboprophylaxis and elastic restraint after total hip or knee arthroplasty.
PROCEDUREPharmacological thromboprophylaxis without elastic compression
Patients benefit from thromboembolism prevention through pharmacological thromboprophylaxis only after total hip or knee arthroplasty.
Sponsors
Clinique Pasteur Lanroze
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of venous thromboembolic events | day 1 ; day 21 ; day 90 | Evaluation of venous thromboembolic events (symptomatic deep vein thrombosis, fatal or non-fatal pulmonary embolism). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life evaluation | 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. |
Countries
France
Contacts
CONTACTRomain Gérard, MD
Outcome results
None listed