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Clinical Trials/NCT04130009
NCT04130009
Completed
Not Applicable

Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

Hawler Medical University0 sites70 target enrollmentMarch 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
Hawler Medical University
Enrollment
70
Primary Endpoint
Visual Analogue score for thigh pain
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2016
End Date
October 20, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sherwan Ahmed Ali Hamawandi

assistant professor of orthopedic surgery

Hawler Medical University

Eligibility Criteria

Inclusion Criteria

  • patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment

Exclusion Criteria

  • Hb less than
  • D.M.,Blood dyscrasia.
  • Any evidence of infection by screening test ESR and CRP. ,
  • BMI more than 30.

Outcomes

Primary Outcomes

Visual Analogue score for thigh pain

Time Frame: 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

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