The Functional Outcome of the Arterial Tourniquet in Total Knee Arthroplasty- a RCT of Bilateral Total Knee Arthroplasties.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tourniquet and Outcome After Total Knee Replacement
- Sponsor
- Odense University Hospital
- Enrollment
- 22
- Primary Endpoint
- Postoperative pain
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Time Frame: 2 weeks postoperatively
Pain at rest evaluated at a visual analogue scale (VAS)
Secondary Outcomes
- 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)