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

Primary Purpose

Blood Loss

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

surgical blade

electrocautery

About this trial

This is an interventional treatment trial for Blood Loss focused on measuring Blood loss, total knee arthroplasty, hot knife, cold knife, unipolar electrocautery, surgical blade

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Orthopaedic department, Faculty of medicine, Thammasat university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

surgical blade

Unipolar electrocautery

Arm Description

Outcomes

Primary Outcome Measures

Blood loss

- 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

inflammation

determine inflammatory response with C-rective protein (CRP) at post-op 48 hours

Knee function

measured with WOMAC

knee range of motion

complication

detected with wound dehiscence, wound infection

Full Information

NCT ID

NCT02108327

First Posted

April 1, 2014

Last Updated

May 8, 2017

Sponsor

Thammasat University

1. Study Identification

Unique Protocol Identification Number

NCT02108327

Brief Title

Blood Loss Between Surgical Blade and Unipolar Electrocautery in TKA

Acronym

TKA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

April 2014 (Actual)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Thammasat University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blood Loss

Keywords

Blood loss, total knee arthroplasty, hot knife, cold knife, unipolar electrocautery, surgical blade

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

surgical blade

Arm Type

Experimental

Arm Title

Unipolar electrocautery

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

surgical blade

Other Intervention Name(s)

hot knife

Intervention Description

Using surgical blade all the time of surgery

Intervention Type

Procedure

Intervention Name(s)

electrocautery

Other Intervention Name(s)

cold knife

Intervention Description

Using electrocautery all the time except at skin incision

Primary Outcome Measure Information:

Title

Blood loss

Description

- detected total blood loss from hemoglobin at 24,48 hours after surgery, maximum Hb drop and blood loss collected in radivac drain

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

inflammation

Description

determine inflammatory response with C-rective protein (CRP) at post-op 48 hours

Time Frame

48 hours

Title

Knee function

Description

measured with WOMAC

Time Frame

3 months

Title

knee range of motion

Time Frame

3 months

Title

complication

Description

detected with wound dehiscence, wound infection

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Orthopaedic department, Faculty of medicine, Thammasat university

City

Klongluang

State/Province

Pathumthani

ZIP/Postal Code

066

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

29968137

Citation

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.

Results Reference

derived

Learn more about this trial

Blood Loss Between Surgical Blade and Unipolar Electrocautery in TKA

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