Efficacy of Lower Tourniquet Pressure During Total Knee Arthroplasty

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Conventional tourniquet pressure; Procedure: Low tourniquet pressure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
      • Recruiting
      • Joint Reconstruction Center, Seoul National University Bundang Hospital
      • Contact: T K Kim, MD, PhD; Phone Number: 82-31-787-7196; Email: osktk@snubh.org
      • Principal Investigator: T K Kim, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure of acquiring bloodless surgical field during operation		after skin incision through the point of tourniquet deflation
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
Thigh pain on the site of tourniquet application	measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale	postoperative 2nd day
Knee pain	measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale	postoperative 2nd day
Skin problem on the site of tourniquet application	It includes ecchymosis, bullae formation and skin necrosis.	posteoperative 2nd day
Nerve palsy		within 7 days after surgery
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: T K Kim, MD, PhD, Joint Reconstruction Center, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 20, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: total knee arthroplasty; tourniquet pressure
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: B-1310/221-007