Adequacy of Exsanguination Between Esmarch Bandages and Simple Leg Elevation in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
To compare the adequacy of exsanguination in the surgical field between the use of the Esmarch bandages elevation and the simple leg elevation.

Official Title
-----------------
Comparison of the Adequacy of Exsanguination Between Esmarch Bandages and Simple Leg Elevation in Minimally Invasive Total Knee Arthroplasty : A Randomized Controlled Trial

Conditions
-----------------
Esmarch Bandages, Simple Leg Elevation

Intervention / Treatment
-----------------
* Other: Esmarch bandages
* Other: simple leg elevation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary osteoarthritis of knee Exclusion Criteria: There are deep vein thrombosis and pulmonary embolism There are bleeding disorder,hypercoagulability,peripheral arterial disease and chronic venous insufficiency Take blood clotting pills Have had total knee arthroplasty BMI > 30
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Esmarch bandages<br> | Other: Esmarch bandages<br>* Esmarch bandage (also known as Esmarch's bandage for surgical haemostasis or Esmarch's tourniquet) in its modern form is a narrow (5 to 10 cm wide) soft rubber bandage that is used to expel venous blood from a limb (exsanguinate) that has had its arterial supply cut off by a tourniquet.<br>|
| Active Comparator: simple leg elevation<br> | Other: simple leg elevation<br>* simple leg elevation 45 degree for 2 minutes is used to expel venous blood from a limb<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fromme-Boezaart surgical field scale | Fromme-Boezaart surgical field scale is visual assessment of surgical field using a 6-point scale (min=0, max=5) 0 mean No bleeding mean Slight bleeding ; no suctioning of blood required mean Slight bleeding ; occasional suctioning required. Surgical field not threatened mean Slight bleeding ; frequent suctioning required. Bleeding threatens surgical filed a few seconds after suction is removed mean Moderate bleeding ; frequent suctioning required. Bleeding threatens surgical field directly after suction is removed mean Severe bleeding ; constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible 0=best possible operating conditions and dryness of the surgical field; 5= worst possible conditions | Immediate after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale: NRS at 24 hrs | NRS is a pain intensity assessment of patients using a 11 point scale (min=0, max=10) 0=no pain 10= worst pain | 24 hours after surgery | 
| Numerical rating scale: NRS at 72 hrs | NRS is a pain intensity assessment of patients using a 11 point scale (min=0, max=10) 0=no pain 10= worst pain | 72 hours after surgery |