Blood Loss Between Surgical Blade and Unipolar Electrocautery in TKA (TKA)

May 8, 2017 updated by: Supakit Kanitnate, Thammasat University

Comparison of Blood Loss Between Surgical Blade and Unipolar Electrocautery in Primary Total Knee Arthroplasty

Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee Arthroplasty (TKA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumthani
      • Klongluang, Pathumthani, Thailand, 066
        • Orthopaedic department, Faculty of medicine, Thammasat university

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

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
  • age 50-85 years old
  • ASA class 1-3

Exclusion Criteria:

  • unable to perform spinal anaesthesia
  • history of coagulation disorder
  • renal impairment (CrCl <30 mL/min) or cirrhosis
  • platelet count < 100,000 or abnormal coagulogram
  • on pacemaker
  • stop anti-platelet or anti-coagulogram less than 7 days

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: surgical blade
Procedure: surgical blade
Using surgical blade all the time of surgery
Other Names:
  • hot knife
Active Comparator: Unipolar electrocautery
Procedure: electrocautery
Using electrocautery all the time except at skin incision
Other Names:
  • cold knife

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: 48 hours
- detected total blood loss from hemoglobin at 24,48 hours after surgery, maximum Hb drop and blood loss collected in radivac drain
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammation
Time Frame: 48 hours
determine inflammatory response with C-rective protein (CRP) at post-op 48 hours
48 hours
Knee function
Time Frame: 3 months
measured with WOMAC
3 months
knee range of motion
Time Frame: 3 months
3 months
complication
Time Frame: 2 weeks
detected with wound dehiscence, wound infection
2 weeks

Collaborators and Investigators

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

Sponsor

Thammasat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 1, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • orthoTU07

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.

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