NCT Number: NCT06228651
The Effect of the Tourniquet in Bilateral Total Knee Replacement
This study describes in a randomised controlled trial how the tourniquet influence the outcome af a total knee replacements
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
The leg without the tourniquet
OtherPrimary outcomes
-
Postoperative pain
Time frame: 2 weeks postoperatively
Pain at rest evaluated at a visual analogue scale (VAS)
Secondary outcomes
-
Forgotten Joint Score (FJS) and Oxford Knee Score (OKS)
Time frame: two weeks, four weeks, three months and one year postop
Patient reported outcome
-
Wound complications and deep vein thrombosis and re-admissions
Time frame: within one year postop
Sponsors and collaborators
Lead sponsor
Odense University Hospital
Other
Registry information
Official study title
The Functional Outcome of the Arterial Tourniquet in Total Knee Arthroplasty- a RCT of Bilateral Total Knee Arthroplasties.
Important dates
- Study start
- 2016
- Primary completion
- 2021
- Study completion
- 2023
- First posted
- Jan 29, 2024
- Registry last updated
- Jan 29, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.