Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

October 15, 2019 updated by: Sherwan Ahmed Ali Hamawandi, Hawler Medical University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TKA with tourniquet
This group was treated by TKA with the use of tourniquet
Procedure: Tourniquet use
Use of Tourniquet in The TKA
Other Names:
  • No tourniquet use
Active Comparator: TKA without tourniquet
This group was treated by TKA without tourniquet
Procedure: Tourniquet use
Use of Tourniquet in The TKA
Other Names:
  • No tourniquet use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The VAS for thigh pain was measured in the day 14 after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawler Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

October 10, 2018

Study Completion (Actual)

October 20, 2018

Study Registration Dates

First Submitted

October 13, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HMU/Sherwan4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Total Knee Arthroplasty

Clinical Trials on Tourniquet use

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe