Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?

NCT06563531 | Recruiting

• 1 other identifier: 2022-04-CPL
• Study Type: interventional
• Target: 1,274
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty Complications

Keywords

hip replacement surgery; knee replacement surgery; thromboprophylaxis; elastic compression

Outcome Measures

Primary Outcomes (1)

• incidence of venous thromboembolic events

  Evaluation of venous thromboembolic events (symptomatic deep vein thrombosis, fatal or non-fatal pulmonary embolism).

  day 1 ; day 21 ; day 90

Secondary Outcomes (1)

• Quality of life evaluation

  day 1 ; day 21 ; day 90

Study Arms (2)

Elastic compression

ACTIVE COMPARATOR

Procedure: Pharmacological thromboprophylaxis and elastic compression

No elastic compression

EXPERIMENTAL

Procedure: Pharmacological thromboprophylaxis without elastic compression

Interventions

Pharmacological thromboprophylaxis and elastic compression PROCEDURE

Patients benefit from thromboembolism prevention through pharmacological thromboprophylaxis and elastic restraint after total hip or knee arthroplasty.

Elastic compression

Pharmacological thromboprophylaxis without elastic compression PROCEDURE

Patients benefit from thromboembolism prevention through pharmacological thromboprophylaxis only after total hip or knee arthroplasty.

No elastic compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Pasteur Lanroze: lead

Study Sites (1)

Clinique Pasteur Lanroze

Brest, 29000, France

RECRUITING

Central Study Contacts

Romain Gérard, MD

CONTACT

+33 2 98 28 98 26; dr.romaingerard@protonmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)