The Effects of Tourniquet Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
Reinflation after early tourniquet deflation
Arthritis+3
+ Joint Diseases
+ Musculoskeletal Diseases
Treatment Study
Summary
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.Total knee arthroplasty(TKA) is mostly performed with tourniquet applied, because it allows decreased intraoperative blood loss, better visualization of surgical field and better cement fixation of the implants, compared to the TKA without using tourniquet. However, there remains a controversy about the timing of tourniquet release, so the tourniquet may be unreleased throughout the whole operation time or released early just after cement fixation of the implants, atc. Early tourniquet release is generally aimed to control hidden arterial bleeding which would not be revealed if the tourniquet was unreleased. This method was reported to reduce arterial bleeding and its related complications, but it was also known that increase intraoperative bleeding, incidence of transfusion, and operation time. On the other hand, late tourniquet release, which the tourniquet is unreleased until the wound is closed, is reported to increase tourniquet-use time and related complications owing to longer tourniquet time, although it gives shorter operation time. The investigators have been used a way of reinflation of tourniquet after early release, once the arterial bleeding was controlled sufficiently, to balance the advantages and disadvantages of the early tourniquet release. The investigators were able to control arterial bleeding during the time the tourniquet was released, and the remained procedures were performed conveniently with good visualization of the surgical field after the tourniquet was reinflated again. However, there was no previous studies about the efficacy and the safety of the way of reinflation after early release of the tourniquet in the literature. Therefore, the investigators ask in this study whether the reinflation after early tourniquet release has advantages over the method of early tourniquet release without reinflation, in terms of efficacy and safety.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.174 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 40 to 90 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Joint Reconstruction Center, Seoul National University Bundang Hospital
Seongnam-si, South KoreaOpen Joint Reconstruction Center, Seoul National University Bundang Hospital in Google Maps