The Effect of the Tourniquet in Bilateral Total Knee Replacement

Not Applicable

Completed

• Conditions: Tourniquet and Outcome After Total Knee Replacement
• Interventions: Device: Tourniquet; Other: The leg without the tourniquet

• Registration Number: NCT06228651
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study Start: 2016-03-14
• Primary Completion: 2021-03-01
• Study Completion: 2023-12-21
• Status Verified: 2024-01
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tourniquet	Tourniquet	The leg with the tourniquet which was inflated during surgery
Control	The leg without the tourniquet	The leg without the tourniquet which was not inflated during surgery

Primary Outcome Measures

Name	Time	Method
Postoperative pain	2 weeks postoperatively	Pain at rest evaluated at a visual analogue scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Wound complications and deep vein thrombosis and re-admissions	within one year postop
Forgotten Joint Score (FJS) and Oxford Knee Score (OKS)	two weeks, four weeks, three months and one year postop	Patient reported outcome