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.
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 patients undergoing total joint arthroplasty. Unlike standard electrocautery, which use monopolar radiofrequency energy, this technology uses bipolar radiofrequency energy combined with a continuous-flow saline at the electrode tip to prevent tissue temperatures from exceeding 100 °C thus minimizing tissue charring. This eliminates the smoke and eschar formation seen with standard electrocautery. The temperature achieved is sufficient to induce a process called Transcollation(TM) which shrinks the collagen fibers in the walls of blood vessels, effectively sealing the blood vessels up to 1mm in diameter, resulting in the reduction of bleeding from soft tissue. Suction is used to remove the saline from the surgical field with the treated tissue turning a light tan color. With normal use, the depth of penetration of this effect is typically less than 2mm. The technology is cleared by the US FDA (510(k)) and EU (CE Mark) for use on soft tissue \& bone and will be used according to its intended packaging indications for use. The current assessment proposes a technique in which a disposable Aquamantys® hand piece is used to treat targeted areas which are bleeding or expected to bleed during surgery. This postmarket study will assess the surgical and economic effectiveness of Aquamantys® System in managing intra-operative blood loss and transfusion rates in patients undergoing septic and aseptic revision TKA.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The use of the saline-coupled bipolar sealing technology (Aquamantys® System, Medtronic Advanced Energy, LLC, Portsmouth, NH, USA) uses bipolar radiofrequency energy combined with a continuous-flow saline at the electrode tip to prevent tissue temperatures from exceeding 100 °C thus minimizing tissue charring. The temperature achieved is sufficient to induce a process called Transcollation(TM) which shrinks the collagen fibers in the walls of blood vessels, effectively sealing the blood vessels up to 1mm in diameter, resulting in the reduction of bleeding from soft tissue.
Orthopädische Klinik Markgröningen gGmbH
Markgröningen, Germany
Blood Loss and Post-Operative Transfusion Rate
To reduce blood loss and post-operative transfusion rates in patients undergoing total joint arthroplasty. This will be achieved using the Aquamantys system. The Aquamantys system provides transcollation which shrinks the collagen fibers in the walls of blood vessels, effectively sealing the blood vessels up to 1mm in diameter, resulting in the reduction of bleeding from soft tissue.
Time frame: 14 days
Operative room and total hospital costs
The data to be collected will include, but is not limited to: copies of the subjects' hospital bills, corresponding Explanation of Benefits (EOB), physician's bill, or itemized hospital bills. The economic form(s) are collected and copies are provided to the sponsor.
Time frame: 14 days
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