Bipolar Sealer Aquamantys Use in Total Knee Replacement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01736644|
Recruitment Status : Unknown
Verified February 2014 by Medtronic Surgical Technologies.
Recruitment status was: Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Arthritis Surgery Infection Inflammation Disability Hemorrhage||Device: Electrocautery Device: Bipolar sealer Aquamantys||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||A Prospective Randomized Control Trial to Compare the Aquamantys System With Standard Electrocautery in Reducing Blood Loss in Primary Total Knee Arthroplasty|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Placebo Comparator: Electrocautery
Use of electrocautery in tourniquet and without tourniquet total knee replacement surgery.
Use of electrocautery in tourniquet and tourniquetless total knee replacement surgery
Active Comparator: Bipolar Sealer Aquamantys
Use of bipolar sealer Aquamantys in tourniquet and tourniquetless total knee replacement surgical procedures.
Device: Bipolar sealer Aquamantys
Aquamantys use in tourniquet and tourniquetless total knee replacement.
- Blood Loss [ Time Frame: upto to 72 hrs after surgery ]The primary outcome will be total blood loss throughout the hospital stay.
- Rehabilitation [ Time Frame: 6-weeks ]Discharge criteria evaluated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736644
|South West London Elective Orthopaedic Center|
|Epsom, Surrey, United Kingdom, Kt18 7EG|
|Newcastle upon Tyne, United Kingdom|
|Principal Investigator:||Richard E Field, Md, PhD, FRCS||SWLEOC|