Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

Study Overview
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Brief Summary
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Tourniquet use during total knee arthroplasty (TKA) improves visibility and reduces intraoperative blood loss. However, tourniquet use may also have a negative impact on early recovery of muscle strength and lower extremity function after TKA.Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B

Detailed Description
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This study started on March 2016 and ends on October 2018. Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B. All patients were followed for a period of two weeks until removal of skin sutures for the following parameters: Amount of blood transfusion done at and after surgery. Amount of blood drained postoperatively through suction drain. Occurrence of postoperative wound hematoma. VAS (Visual analogue score) for thigh pain at 1st day and (2) weeks postoperatively. Clinical DVT.

Official Title
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Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Procedure: Tourniquet use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment Exclusion Criteria: Hb less than 12. D.M.,Blood dyscrasia. Any evidence of infection by screening test ESR and CRP. , BMI more than 30.

Ages Eligible for Study
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Minimum Age: 48 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is comparative study between two groups one treated by Total knee with tourniquet and other group without tourniquet
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TKA with tourniquet<br>This group was treated by TKA with the use of tourniquet | Procedure: Tourniquet use<br>* Use of Tourniquet in The TKA<br>* Other names: No tourniquet use;|
| Active Comparator: TKA without tourniquet<br>This group was treated by TKA without tourniquet | Procedure: Tourniquet use<br>* Use of Tourniquet in The TKA<br>* Other names: No tourniquet use;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue score for thigh pain | This is measurement of the degree of thigh pain after operation which range from zero to 10 | The VAS for thigh pain was measured in the day 14 after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thigh pain, Total knee Arthroplasty, Tourniquet