Clinical Trials Directory

Trials / Completed

CompletedNCT06228651

The Effect of the Tourniquet in Bilateral Total Knee Replacement

The Functional Outcome of the Arterial Tourniquet in Total Knee Arthroplasty- a RCT of Bilateral Total Knee Arthroplasties.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Odense University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICETourniquet
OTHERThe leg without the tourniquet

Timeline

Start date
2016-03-14
Primary completion
2021-03-01
Completion
2023-12-21
First posted
2024-01-29
Last updated
2024-01-29

Source: ClinicalTrials.gov record NCT06228651. Inclusion in this directory is not an endorsement.