Blood Loss Between Surgical Blade and Unipolar Electrocau... | NCT02108327

Studies
Blood Loss Between Surgical Blade and Unipolar Electrocautery in TKA

NCT02108327

Sponsor

Thammasat University

Status

Completed

Last Update Posted

May 9, 2017Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Blood Loss

Interventions

surgical blade
electrocautery

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014Actual

Primary Completion Date

Feb 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Apr 1, 2014

First Submission Date that Met QC Criteria

Apr 8, 2014

First Posted Date

Apr 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2017

Last Update Posted Date

May 9, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgical blade	Experimental		Procedure: surgical blade
Unipolar electrocautery	Active Comparator		Procedure: electrocautery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgical blade	Procedure	Using surgical blade all the time of surgery	surgical blade

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
inflammation	determine inflammatory response with C-rective protein (CRP) at post-op 48 hours	48 hours
Knee function	measured with WOMAC

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopaedic department, Faculty of medicine, Thammasat university		Klongluang	Changwat Pathum Thani	066	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29968137	Derived	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.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004564	Electrocoagulation
D019092	Conization

ID	Term
D002425	Cautery
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative