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Efficacy of Lower Tourniquet Pressure During Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993758
Recruitment Status : Unknown
Verified May 2014 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Low tourniquet pressure Procedure: Conventional tourniquet pressure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Using Lower Tourniquet Pressure During Total Knee Arthroplasty: Comparison With Conventional Tourniquet Pressure Group
Study Start Date : November 2013
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Conventional tourniquet pressure
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.
Procedure: Conventional tourniquet pressure
Tourniquet pressure set as 150mmHg above the systolic blood pressure just before tourniquet inflation

Experimental: Low tourniquet pressure
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.
Procedure: Low tourniquet pressure
Tourniquet pressure set as 120mmHg above the systolic blood pressure just before tourniquet inflation




Primary Outcome Measures :
  1. Acquisition of bloodless surgical field just after skin incision [ Time Frame: just after skin incision during operation ]
    Dichotomous variable determined during operation by operator (Yes or No)


Secondary Outcome Measures :
  1. Failure of acquiring bloodless surgical field during operation [ Time Frame: after skin incision through the point of tourniquet deflation ]
  2. Increasement of tourniquet pressure to acquire bloodless surgical field [ Time Frame: after skin incision though the point of tourniquet deflation ]
    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.

  3. Thigh pain on the site of tourniquet application [ Time Frame: postoperative 2nd day ]
    measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale

  4. Knee pain [ Time Frame: postoperative 2nd day ]
    measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale

  5. Skin problem on the site of tourniquet application [ Time Frame: posteoperative 2nd day ]
    It includes ecchymosis, bullae formation and skin necrosis.

  6. Nerve palsy [ Time Frame: within 7 days after surgery ]
  7. symptomatic venous-thromboembolism [ Time Frame: within 7 days after surgery ]
    It includes deep vein thrombosis and pulmonary embolism which are symptomatic and diagnosed by confirmative test, such as CT angiogram.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993758


Contacts
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Contact: T K Kim, MD, PhD 82-31-787-7196 osktk@snubh.org

Locations
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Korea, Republic of
Joint Reconstruction Center, Seoul National University Bundang Hospital Recruiting
Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: T K Kim, MD, PhD    82-31-787-7196    osktk@snubh.org   
Principal Investigator: T K Kim, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: T K Kim, MD, PhD Joint Reconstruction Center, Seoul National University Bundang Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01993758    
Other Study ID Numbers: B-1310/221-007
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014
Keywords provided by Seoul National University Hospital:
tourniquet pressure
total knee arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases