Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

NCT ID: NCT04130009

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2018-10-20

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.

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TKA with tourniquet

This group was treated by TKA with the use of tourniquet

Group Type: ACTIVE_COMPARATOR

Tourniquet use

Intervention Type: PROCEDURE

Use of Tourniquet in The TKA

TKA without tourniquet

This group was treated by TKA without tourniquet

Group Type: ACTIVE_COMPARATOR

Tourniquet use

Intervention Type: PROCEDURE

Use of Tourniquet in The TKA

Interventions

Tourniquet use

Use of Tourniquet in The TKA

Intervention Type: PROCEDURE

Other Intervention Names

No tourniquet use

Eligibility Criteria

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.

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hawler Medical University

OTHER

Sponsor Role: lead

Responsible Party

Sherwan Ahmed Ali Hamawandi

assistant professor of orthopedic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HMU/Sherwan4

Identifier Type: -

Identifier Source: org_study_id