Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06228651
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2024-01-19
Brief Title:
The Effect of the Tourniquet in Bilateral Total Knee Replacement
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
The Functional Outcome of the Arterial Tourniquet in Total Knee Arthroplasty- a RCT of Bilateral Total Knee Arthroplasties
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study describes in a randomised controlled trial how the tourniquet influence the outcome af a total knee replacements
Detailed Description:
Background Tourniquet application during total knee arthroplasty TKA is a common practice aimed at reducing intraoperative bleeding However concerns have been raised about potential tissue damage from ischemia and reperfusion injury
Objectives This study examines the effects of tourniquet use during TKA on postoperative functional outcomes including pain range of motion ROM and patient-reported outcomes PROMs
Methods In a fast-track surgical setting a prospective randomized double-blinded trial was conducted with patients undergoing bilateral TKA Tourniquets were applied to one knee while the contralateral knee served as a control Evaluations were conducted at two and four weeks and at three and twelve months postoperatively employing paired t-tests and mixed-effects linear modeling for data analysis
Objectives This study examines the effects of tourniquet use during TKA on postoperative functional outcomes including pain range of motion ROM and patient-reported outcomes PROMs
Methods In a fast-track surgical setting a prospective randomized double-blinded trial was conducted with patients undergoing bilateral TKA Tourniquets were applied to one knee while the contralateral knee served as a control Evaluations were conducted at two and four weeks and at three and twelve months postoperatively employing paired t-tests and mixed-effects linear modeling for data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None