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

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ClinicalTrials.gov Identifier: NCT02108327
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Supakit Kanitnate, Thammasat University

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

Condition or disease Intervention/treatment Phase
Blood Loss Procedure: surgical blade Procedure: electrocautery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Blood Loss Between Surgical Blade and Unipolar Electrocautery in Primary Total Knee Arthroplasty
Actual Study Start Date : April 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: surgical blade Procedure: surgical blade
Using surgical blade all the time of surgery
Other Name: hot knife

Active Comparator: Unipolar electrocautery Procedure: electrocautery
Using electrocautery all the time except at skin incision
Other Name: cold knife




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. inflammation [ Time Frame: 48 hours ]
    determine inflammatory response with C-rective protein (CRP) at post-op 48 hours

  2. Knee function [ Time Frame: 3 months ]
    measured with WOMAC

  3. knee range of motion [ Time Frame: 3 months ]
  4. complication [ Time Frame: 2 weeks ]
    detected with wound dehiscence, wound infection



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108327


Locations
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Thailand
Orthopaedic department, Faculty of medicine, Thammasat university
Klongluang, Pathumthani, Thailand, 066
Sponsors and Collaborators
Thammasat University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Supakit Kanitnate, principal investigator, Thammasat University
ClinicalTrials.gov Identifier: NCT02108327     History of Changes
Other Study ID Numbers: orthoTU07
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Keywords provided by Supakit Kanitnate, Thammasat University:
Blood loss
total knee arthroplasty
hot knife
cold knife
unipolar electrocautery
surgical blade

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes