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NCT02108327 Clinical Trial

Blood Loss Between Surgical Blade and Unipolar Electrocautery in TKA

Blood Loss Clinical Trial

— TKA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02108327
Other study ID # orthoTU07
Secondary ID
Status Completed
Phase N/A
First received April 1, 2014
Last updated May 8, 2017
Start date April 2014
Est. completion date May 2015

Study information
Verified date May 2017
Source Thammasat University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date May 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• surgical blade
Using surgical blade all the time of surgery
• electrocautery
Using electrocautery all the time except at skin incision

Locations
Country Name City State
Thailand Orthopaedic department, Faculty of medicine, Thammasat university Klongluang Pathumthani

Sponsors (1)
Lead Sponsor Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

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