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OpenTrials
Completed

NCT Number: NCT02108327

Blood Loss Between Surgical Blade and Unipolar Electrocautery in TKA

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

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Key information

Conditions

Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic department, Faculty of medicine, Thammasat university

Klongluang, Changwat Pathum Thani, 066, Thailand

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Surgical Blade

Procedure

Using surgical blade all the time of surgery

Other names: hot knife

Electrocautery

Procedure

Using electrocautery all the time except at skin incision

Other names: cold knife

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Acronym: TKA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2014
Registry last updated
May 9, 2017

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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