The Effect of the Tourniquet in Bilateral Total Knee Replacement

O

Odense University Hospital

Status

Completed

Conditions

Tourniquet and Outcome After Total Knee Replacement

Treatments

Other: The leg without the tourniquet
Device: Tourniquet

Study type

Interventional

Funder types

Other

Identifiers

NCT06228651
s-20150100

Details and patient eligibility

About

This study describes in a randomised controlled trial how the tourniquet influence the outcome af a total knee replacements

Full 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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged 18 years or older, planned for bilateral cemented primary TKA due to osteoarthritis during the same session. and showed a uniform degree of osteoarthritis determined by the Kellgren-Lawrence classification

Exclusion criteria

non-Danish speaking patients, unable to cooperate for VAS scoring, coagulation disorders, salicylate-induced asthma, severe thrombocytopenia, serious heart failure, severe liver failure, hypovolemia (any cause), dehydration, angioedema, bronchospasm, undergoing lithium treatment, suspected or manifest gastrointestinal bleeding, cerebrovascular bleeding, high postoperative bleeding risk or delayed hemostasis, hypersensitivity to adrenaline, sympathomimetics or excipients , hypertrophic or ischemic heart disease, undergoing dihydroergotamine treatment and thyrotoxicosis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

22 participants in 2 patient groups

Tourniquet
Active Comparator group
Description:
The leg with the tourniquet which was inflated during surgery
Treatment:
Device: Tourniquet
Control
Active Comparator group
Description:
The leg without the tourniquet which was not inflated during surgery
Treatment:
Other: The leg without the tourniquet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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