Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563531
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None