Efficacy of Lower Tourniquet Pressure During Total Knee Arthroplasty
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Low tourniquet pressure
Conventional tourniquet pressure
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring tourniquet pressure, total knee arthroplasty
Eligibility Criteria
Inclusion Criteria:
- The patients undergoing total knee arthroplasty
Exclusion Criteria:
- Systolic blood pressure measured at ward > 200mmHg
- Thigh circumference > 78cm
- Anesthesia other than spinal anesthesia
- Simultaneous bilateral total knee arthroplasty
- The patients who disagreed the enrollment of this study
Sites / Locations
- Joint Reconstruction Center, Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional tourniquet pressure
Low tourniquet pressure
Arm Description
The patients in this group will undertake total knee arthroplasty under conventional tourniquet pressure, which will be set as the pressure added by 150mmHg on the last systolic blood pressure just before tourniquet inflation.
The patients in this group will undertake total knee arthroplasty under low tourniquet pressure, which will be set as the pressure added by 120mmHg on the last systolic blood pressure just before tourniquet inflation.
Outcomes
Primary Outcome Measures
Acquisition of bloodless surgical field just after skin incision
Dichotomous variable determined during operation by operator (Yes or No)
Secondary Outcome Measures
Failure of acquiring bloodless surgical field during operation
Increasement of tourniquet pressure to acquire bloodless surgical field
We will increase the tourniquet pressure by 30mmHg from the initial tourniquet pressure, if we will fail to achieve bloodless surgical field during operation. The increasement of tourniquet pressure will be recorded if it will be needed during operation.
Thigh pain on the site of tourniquet application
measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale
Knee pain
measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale
Skin problem on the site of tourniquet application
It includes ecchymosis, bullae formation and skin necrosis.
Nerve palsy
symptomatic venous-thromboembolism
It includes deep vein thrombosis and pulmonary embolism which are symptomatic and diagnosed by confirmative test, such as CT angiogram.
Full Information
NCT ID
NCT01993758
First Posted
November 19, 2013
Last Updated
May 20, 2014
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01993758
Brief Title
Efficacy of Lower Tourniquet Pressure During Total Knee Arthroplasty
Official Title
The Efficacy of Using Lower Tourniquet Pressure During Total Knee Arthroplasty: Comparison With Conventional Tourniquet Pressure Group
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to determine whether the lower tourniquet pressure, which is set by adding 120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet inflation, are efficient and safe during total knee arthroplasty, compared with the conventional tourniquet pressure: 150mmHg above the systolic blood pressure before tourniquet inflation.
Detailed Description
We will compare the two groups of patients undergoing total knee arthroplasty, which the tourniquet pressure will be set differently: systolic blood pressure plus 120mmHg vs. systolic blood pressure plus 150mmHg, the conventional method, in terms of efficacy and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
tourniquet pressure, total knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional tourniquet pressure
Arm Type
Active Comparator
Arm Description
The patients in this group will undertake total knee arthroplasty under conventional tourniquet pressure, which will be set as the pressure added by 150mmHg on the last systolic blood pressure just before tourniquet inflation.
Arm Title
Low tourniquet pressure
Arm Type
Experimental
Arm Description
The patients in this group will undertake total knee arthroplasty under low tourniquet pressure, which will be set as the pressure added by 120mmHg on the last systolic blood pressure just before tourniquet inflation.
Intervention Type
Procedure
Intervention Name(s)
Low tourniquet pressure
Intervention Description
Tourniquet pressure set as 120mmHg above the systolic blood pressure just before tourniquet inflation
Intervention Type
Procedure
Intervention Name(s)
Conventional tourniquet pressure
Intervention Description
Tourniquet pressure set as 150mmHg above the systolic blood pressure just before tourniquet inflation
Primary Outcome Measure Information:
Title
Acquisition of bloodless surgical field just after skin incision
Description
Dichotomous variable determined during operation by operator (Yes or No)
Time Frame
just after skin incision during operation
Secondary Outcome Measure Information:
Title
Failure of acquiring bloodless surgical field during operation
Time Frame
after skin incision through the point of tourniquet deflation
Title
Increasement of tourniquet pressure to acquire bloodless surgical field
Description
We will increase the tourniquet pressure by 30mmHg from the initial tourniquet pressure, if we will fail to achieve bloodless surgical field during operation. The increasement of tourniquet pressure will be recorded if it will be needed during operation.
Time Frame
after skin incision though the point of tourniquet deflation
Title
Thigh pain on the site of tourniquet application
Description
measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale
Time Frame
postoperative 2nd day
Title
Knee pain
Description
measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale
Time Frame
postoperative 2nd day
Title
Skin problem on the site of tourniquet application
Description
It includes ecchymosis, bullae formation and skin necrosis.
Time Frame
posteoperative 2nd day
Title
Nerve palsy
Time Frame
within 7 days after surgery
Title
symptomatic venous-thromboembolism
Description
It includes deep vein thrombosis and pulmonary embolism which are symptomatic and diagnosed by confirmative test, such as CT angiogram.
Time Frame
within 7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients undergoing total knee arthroplasty
Exclusion Criteria:
Systolic blood pressure measured at ward > 200mmHg
Thigh circumference > 78cm
Anesthesia other than spinal anesthesia
Simultaneous bilateral total knee arthroplasty
The patients who disagreed the enrollment of this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
T K Kim, MD, PhD
Phone
82-31-787-7196
Email
osktk@snubh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T K Kim, MD, PhD
Organizational Affiliation
Joint Reconstruction Center, Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint Reconstruction Center, Seoul National University Bundang Hospital
City
Seongnam-Si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
T K Kim, MD, PhD
Phone
82-31-787-7196
Email
osktk@snubh.org
First Name & Middle Initial & Last Name & Degree
T K Kim, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
31159799
Citation
Kim TK, Bamne AB, Sim JA, Park JH, Na YG. Is lower tourniquet pressure during total knee arthroplasty effective? A prospective randomized controlled trial. BMC Musculoskelet Disord. 2019 Jun 4;20(1):275. doi: 10.1186/s12891-019-2636-7.
Results Reference
derived
Learn more about this trial
Efficacy of Lower Tourniquet Pressure During Total Knee Arthroplasty
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