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Completed

NCT Number: NCT04130009

Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

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

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Key information

Conditions

Total Knee Arthroplasty

Age range

48 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tourniquet Use

Procedure

Use of Tourniquet in The TKA

Other names: No tourniquet use

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2019
Registry last updated
Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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