Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Procedure: Tourniquet use

• Registration Number: NCT04130009
• Lead Sponsor: Hawler Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2018-10-10
• Study Completion: 2018-10-20
• Status Verified: 2019-10
• Study First Submitted: 2019-10-13
• Study First Submitted QC: 2019-10-15
• Last Update Submitted: 2019-10-15
• Study First Posted: 2019-10-17
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TKA without tourniquet	Tourniquet use	This group was treated by TKA without tourniquet
TKA with tourniquet	Tourniquet use	This group was treated by TKA with the use of tourniquet

Primary Outcome Measures

Name	Time	Method
Visual Analogue score for thigh pain	The VAS for thigh pain was measured in the day 14 after operation	This is measurement of the degree of thigh pain after operation which range from zero to 10