- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01832272
Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
May 18, 2014 updated by: Tae Kyun Kim, Seoul National University Hospital
The Effects of Tourniquet Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
This study is aimed to determine the efficacy and the safety of the tourniquet reinflation after early tourniquet release in total knee arthroplasty, compared to the method of early deflation without reinflation.
The investigators hypothesized that the reinflation after early release of the tourniquet would be effective in terms of improved visualization of the surgical field and decreased operation time and blood loss, whereas it would increase tourniquet-related complication due to longer tourniquet-use time.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
174
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Gyeonggi-do
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Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
- Recruiting
- Joint Reconstruction Center, Seoul National University Bundang Hospital
-
Contact:
- Tae Kyun Kim, MD, PhD
- Phone Number: 82-31-787-7196
- Email: osktk@snubh.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of primary osteoarthritis of the knee
- Scheduled for elective total knee arthroplasty
- Written signed consent
Exclusion Criteria:
- Revision TKA
- Diagnosis other than primary osteoarthritis
- Intra-articular indwelling drainage
- Refusing participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reinflation after early deflation
The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled (Reinflation after early tourniquet deflation).
|
The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled
Other Names:
|
No Intervention: No reinflation after early deflation
The tourniquet is released after cement implant fixation, and remained deflated without reinflation, even after hemostasis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operation time
Time Frame: from skin incision to wound closure
|
Total time between initial skin incision and wound closure
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from skin incision to wound closure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tourniquet time
Time Frame: total sum of time between inflation and deflation of tourniquet
|
Total time of tourniquet-use during the operation which defined from skin incision to the wound closure
|
total sum of time between inflation and deflation of tourniquet
|
Difficulty of the operation
Time Frame: from skin incision to wound closure
|
Measured by the number of operative field clearance using gauze to make the remained procedure convenient
|
from skin incision to wound closure
|
Incidence of transfusion
Time Frame: within 2weeks after surgery
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The incidence of allogenic or autologous (preoperative autologous blood donation) transfusion after surgery due to significant hemoglobin drop within 2weeks after surgery
|
within 2weeks after surgery
|
Wound complications
Time Frame: on the 2nd and 14th day after surgery
|
wound complications evaluated on the 2nd and 14th day after surgery, such as ecchymosis, subcutaneous hematoma, hemarthrosis, and oozing
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on the 2nd and 14th day after surgery
|
Thigh complications
Time Frame: within 2 weeks
|
Thigh complication due to the tourniquet, such as ecchymosis, skin bullae, and skin necrosis around the area of tourniquet application
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within 2 weeks
|
Venous thromboembolism
Time Frame: within 2 weeks
|
symptomatic deep vein thrombosis and pulmonary embolism, detected within 2weeks after surgery
|
within 2 weeks
|
Postoperative pain (VAS)
Time Frame: on the 2nd and 5th day after surgery.
|
An independent investigator who was blinded to randomization assessed knee and thigh pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain) on the 2nd and 5th day after surgery.
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on the 2nd and 5th day after surgery.
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More painful site
Time Frame: on the 2nd and 5th day after surgery
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An independent investigator who was blinded to randomization assessed the more painful site either knee (operation site) or thigh (tourniquet application site) on the 2nd and 5th day after surgery.
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on the 2nd and 5th day after surgery
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More painful side in SBTKA
Time Frame: on the 2nd and 5th day after surgery.
|
An independent investigator who was blinded to randomization assessed the more painful side in patients undergoing simultaneous bilateral TKA (SBTKA), whose each knee will be allocated into experimental and control group, respectively.
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on the 2nd and 5th day after surgery.
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Amount of drainage
Time Frame: Until the drainage removal, average of 1 to 2 days after surgery
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Total amount of subcutaneous indwelled drainage before removal of it.
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Until the drainage removal, average of 1 to 2 days after surgery
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Hemoglobin drop on the 2nd day after surgery
Time Frame: On the 2nd day after surgery
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The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 2nd day from the preoperative value
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On the 2nd day after surgery
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Hemoglobin drop on the 5th day after surgery
Time Frame: On the 5th day after surgery
|
The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 5th day from the preoperative value
|
On the 5th day after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tae Kyun Kim, MD, PhD, Joint Reconstruction Center, Seoul National University Bundang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
January 1, 2015
Study Registration Dates
First Submitted
February 20, 2013
First Submitted That Met QC Criteria
April 15, 2013
First Posted (Estimate)
April 16, 2013
Study Record Updates
Last Update Posted (Estimate)
May 20, 2014
Last Update Submitted That Met QC Criteria
May 18, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1206/158-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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