Status:
COMPLETED
Surgical / Economic Effect of the Aquamantys System in Blood Management for Aseptic and Septic Revision TKA
Lead Sponsor:
Medtronic Surgical Technologies
Conditions:
Infection of Total Knee Joint Prosthesis
Aseptic Loosening of Prosthetic Joint
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 sept...
Detailed Description
The use of the saline-coupled bipolar sealing technology (Aquamantys® System, Medtronic Advanced Energy, LLC, Portsmouth, NH, USA) represents a modern approach to reducing perioperative blood loss in ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02266407
Start Date
June 1 2012
End Date
September 1 2012
Last Update
February 27 2020
Active Locations (1)
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1
Orthopädische Klinik Markgröningen gGmbH
Markgröningen, Germany, 71706