NCT02108327

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

April 1, 2014

Last Update Submit

May 8, 2017

Conditions

Blood Loss

Keywords

Blood losstotal knee arthroplastyhot knifecold knifeunipolar electrocauterysurgical blade

Outcome Measures

Primary Outcomes (1)

  • Blood loss

    \- 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 Outcomes (4)

  • inflammation

    48 hours

  • Knee function

    3 months

  • knee range of motion

    3 months

  • complication

    2 weeks

Study Arms (2)

surgical blade

EXPERIMENTAL
Procedure: surgical blade

Unipolar electrocautery

ACTIVE COMPARATOR
Procedure: electrocautery

Interventions

surgical bladePROCEDURE

Using surgical blade all the time of surgery

Also known as: hot knife
surgical blade
electrocauteryPROCEDURE

Using electrocautery all the time except at skin incision

Also known as: cold knife
Unipolar electrocautery

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic department, Faculty of medicine, Thammasat university

Klongluang, Changwat Pathum Thani, 066, Thailand

Location

Related Publications (1)

  • Tammachote N, Kanitnate S. Electric cautery does not reduce blood loss in primary total knee arthroplasty compared with scalpel only surgery a double-blinded randomized controlled trial. Int Orthop. 2018 Dec;42(12):2755-2760. doi: 10.1007/s00264-018-4048-y. Epub 2018 Jul 3.

    PMID: 29968137DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

ElectrocoagulationConization

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CauteryTherapeuticsAblation TechniquesSurgical Procedures, OperativeBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 9, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

TH(1)