An interventional study of Tourniquet and The leg without the tourniquet in Tourniquet and Outcome After Total Knee Replacement, sponsored by Odense University Hospital. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Treatment
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.
Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
The leg with the tourniquet which was inflated during surgery
Device: Tourniquet
The leg without the tourniquet which was not inflated during surgery
Other: The leg without the tourniquet
Postoperative pain
Pain at rest evaluated at a visual analogue scale (VAS)
Time frame: 2 weeks postoperatively
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Odense University Hospital