Status:
RECRUITING
Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?
Lead Sponsor:
Clinique Pasteur Lanroze
Conditions:
Arthroplasty Complications
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2026
Estimated Enrollment :
1274 Patients enrolled
Trial Details
Trial ID
NCT06563531
Start Date
November 15 2024
End Date
July 15 2026
Last Update
November 20 2024
Active Locations (1)
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1
Clinique Pasteur Lanroze
Brest, France, 29000