Efficacy of Lower Tourniquet Pressure During Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

The Efficacy of Using Lower Tourniquet Pressure During Total Knee Arthroplasty: Comparison With Conventional Tourniquet Pressure Group

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01993758
• Other study ID #: B-1310/221-007
• Status: Recruiting
• Phase: N/A
• First received: November 19, 2013
• Last updated: May 20, 2014
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: T K Kim, MD, PhD
• Phone: 82-31-787-7196
• Email: osktk[@]snubh.org
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Low tourniquet pressure
Tourniquet pressure set as 120mmHg above the systolic blood pressure just before tourniquet inflation
• Conventional tourniquet pressure
Tourniquet pressure set as 150mmHg above the systolic blood pressure just before tourniquet inflation

Locations

Country	Name	City	State
Korea, Republic of	Joint Reconstruction Center, Seoul National University Bundang Hospital	Seongnam-Si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition of bloodless surgical field just after skin incision	Dichotomous variable determined during operation by operator (Yes or No)	just after skin incision during operation	No
Secondary	Failure of acquiring bloodless surgical field during operation		after skin incision through the point of tourniquet deflation	No
Secondary	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.	after skin incision though the point of tourniquet deflation	No
Secondary	Thigh pain on the site of tourniquet application	measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale	postoperative 2nd day	No
Secondary	Knee pain	measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale	postoperative 2nd day	No
Secondary	Skin problem on the site of tourniquet application	It includes ecchymosis, bullae formation and skin necrosis.	posteoperative 2nd day	Yes
Secondary	Nerve palsy		within 7 days after surgery	Yes
Secondary	symptomatic venous-thromboembolism	It includes deep vein thrombosis and pulmonary embolism which are symptomatic and diagnosed by confirmative test, such as CT angiogram.	within 7 days after surgery	Yes