Surgical / Economic Effect of the Aquamantys System in Blood Management for Aseptic and Septic Re⦠(NCT02266407) | Clinical Trial Compass
CompletedNot Applicable
Surgical / Economic Effect of the Aquamantys System in Blood Management for Aseptic and Septic Revision TKA
Germany80 participantsStarted 2012-06
Plain-language summary
To assess the surgical and economic effectiveness of the Aquamantys System in managing intra- and post-operative blood loss, and reducing transfusion needs in patients undergoing both aseptic and septic revision total knee arthroplasty.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
* The patient is greater than 18 years of age
* Patients following failure of primary, unilateral TKA
* The degree of revision requires the use of an extended osteotomy for component removal
* Patient has participated in the informed consent process and has signed an Ethics Committee approved informed consent
Exclusion Criteria
* Patients presenting with a history of bleeding disorders and/or are on chronic blood anticoagulation therapy
* Patients presenting with an internal cardiac defibrillator
* Women who are pregnant
* Prisoner or transient
* Recent history of known narcotic abuse
* Any significant psychological disturbance past or present, that could impair the consent process or ability to complete subject self-report questionnaires
* Subject unwilling to undergo blood transfusion, if necessary