The Effect of the Tourniquet in Bilateral Total Knee Replacement

Odense University Hospital22 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tourniquet and Outcome After Total Knee Replacement

Interventions

TourniquetDEVICE

The leg without the tourniquetOTHER

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Postoperative pain

Pain at rest evaluated at a visual analogue scale (VAS)

Time frame: 2 weeks postoperatively

Secondary Outcomes

Forgotten Joint Score (FJS) and Oxford Knee Score (OKS)

Patient reported outcome

Time frame: two weeks, four weeks, three months and one year postop

Wound complications and deep vein thrombosis and re-admissions

Time frame: within one year postop

Data from ClinicalTrials.gov

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