Surgical / Economic Effect of the Aquamantys System in Blood Management for Aseptic and Septic Revision TKA

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Surgical and Economic Effect of the Aquamantys System in Blood Management During and Following Aseptic and Septic Revision TKA

Conditions
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Infection of Total Knee Joint Prosthesis, Aseptic Loosening of Prosthetic Joint

Intervention / Treatment
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* Procedure: Aquamantys System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ASEPTIC Revision TKA & Aquamantys System<br>Single-stage revision TKA cases performed for aseptic failure requiring an extended osteotomy for component removal and intra-operative blood management (bipolar sealing) with the Aquamantys® System. These will be compared to in-house matched historic control using patients presenting with ASEPTIC failed primary TKA and revised without use of the Aquamantys® System. | Procedure: Aquamantys System<br>* 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.<br>|
| Active Comparator: SEPTIC Revision TKA & Aquamantys System<br>Single-stage revision TKA cases performed for septic failure requiring an extended osteotomy for component removal and intra-operative blood management (bipolar sealing) with the Aquamantys® System. These will be compared to in-house matched historic control using patients presenting with SEPTIC failed primary TKA revised without use of the Aquamantys® System. | Procedure: Aquamantys System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revision TKA, Septic, Aseptic, Transfusion, Blood Loss