Actively Recruiting
Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?
Led by Clinique Pasteur Lanroze · Updated on 2026-04-06
1274
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the necessity of elastic restraints in preventing venous thrombosis and pulmonary embolism after hip and knee replacement surgery. These serious complications can be potentially prevented, but the benefits of using elastic compression devices alongside pharmacological treatment remain unclear. The study investigates whether using medication alone is as effective as combining medication with elastic restraints in these surgeries. Participants will be randomly assigned to one of two groups: one receiving pharmacological thromboprophylaxis combined with elastic compression restraints, and the other receiving only pharmacological thromboprophylaxis without elastic compression. The study will assess outcomes up to 90 days after prosthetic surgery to compare these approaches. Throughout the study, researchers will monitor the incidence of venous thromboembolic events on days 1, 21, and 90 post-surgery. Quality of life will also be evaluated at these time points. Participants will undergo regular assessments to track safety and effectiveness over the three-month period following their surgery.
CONDITIONS
Brief Title
Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Adults aged 18 years or older
You will not qualify if you...
- 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 less than 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)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 days
Participants receive pharmacological thromboprophylaxis with or without elastic compression after hip or knee prosthetic surgery to prevent venous thromboembolic events.
Visits on day 1 and day 21
Duration - Up to 90 days from surgery
Participants are monitored for the incidence of venous thromboembolic events and quality of life evaluation.
Visit at day 90
Trial Site Locations
Total: 1 location
1
Clinique Pasteur Lanroze
Brest, France, 29000
Actively Recruiting
Research Team
R
Romain Gérard, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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