Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

Total Knee Arthroplasty Clinical Trial

Official title:

Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04130009
• Other study ID #: HMU/Sherwan4
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: October 20, 2018

Study information

• Verified date: October 2019
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 20, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Years to 82 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Procedure:
• Tourniquet use
Use of Tourniquet in The TKA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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