Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
The Effects of Tourniquet Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
1 other identifier
interventional
174
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 20, 2013
CompletedFirst Posted
Study publicly available on registry
April 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMay 20, 2014
May 1, 2014
1.8 years
February 20, 2013
May 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Operation time
Total time between initial skin incision and wound closure
from skin incision to wound closure
Secondary Outcomes (12)
Tourniquet time
total sum of time between inflation and deflation of tourniquet
Difficulty of the operation
from skin incision to wound closure
Incidence of transfusion
within 2weeks after surgery
Wound complications
on the 2nd and 14th day after surgery
Thigh complications
within 2 weeks
- +7 more secondary outcomes
Study Arms (2)
Reinflation after early deflation
EXPERIMENTALThe tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled (Reinflation after early tourniquet deflation).
No reinflation after early deflation
NO INTERVENTIONThe tourniquet is released after cement implant fixation, and remained deflated without reinflation, even after hemostasis.
Interventions
The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled
Eligibility Criteria
You may qualify if:
- Diagnosis of primary osteoarthritis of the knee
- Scheduled for elective total knee arthroplasty
- Written signed consent
You may not qualify if:
- Revision TKA
- Diagnosis other than primary osteoarthritis
- Intra-articular indwelling drainage
- Refusing participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Joint Reconstruction Center, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tae Kyun Kim, MD, PhD
Joint Reconstruction Center, Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Direcor, Joint reconstruction center, SNUBH
Study Record Dates
First Submitted
February 20, 2013
First Posted
April 16, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2014
Study Completion
January 1, 2015
Last Updated
May 20, 2014
Record last verified: 2014-05