NCT06563531 Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?
| NCT ID | NCT06563531 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Clinique Pasteur Lanroze |
| Condition | Arthroplasty Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,274 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2027-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,274 participants in total. It began in 2024-11-15 with a primary completion date of 2027-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06563531 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arthroplasty Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06563531 currently recruiting?
Yes, NCT06563531 is actively recruiting participants. Contact the research team at dr.romaingerard@protonmail.com for enrollment information.
Where is the NCT06563531 trial being conducted?
This trial is being conducted at Brest, France.
Who is sponsoring the NCT06563531 clinical trial?
NCT06563531 is sponsored by Clinique Pasteur Lanroze. The trial plans to enroll 1,274 participants.