Investigating the necessity of elastic restraints after hip and knee surgery
Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?
This study is testing if using just medication is as good as using both medication and elastic straps to prevent blood clots in people having hip or knee replacement surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1274 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinique Pasteur Lanroze Academic / other |
| Locations | 1 site (Brest) |
| Trial ID | NCT06563531 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for first-line, non-traumatic total hip or knee arthroplasty who are part of an Enhanced Rehabilitation after Surgery protocol.
Not a fit: Patients with pre-existing co-morbidities requiring long-term anticoagulation or those with coagulation disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more streamlined postoperative care for patients undergoing hip and knee replacements, potentially reducing the need for elastic restraints.
How similar studies have performed: While several studies have explored the use of elastic restraints in thromboembolism prevention, this specific investigation into the non-inferiority of pharmacological treatment without mechanical devices is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Brest
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.