Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06563531

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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