Aseptic Loosening of Prosthetic Joint, Infection of Total Knee Joint Prosthesis
Conditions
Keywords
Revision TKA, Septic, Aseptic, Transfusion, Blood Loss
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 septic revision total knee arthroplasty.
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 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.
Interventions
PROCEDUREAquamantys System
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.
Sponsors
Medtronic Surgical Technologies
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss and Post-Operative Transfusion Rate | 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative room and total hospital costs | 14 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin and hematocrit from baseline (pre-op) | 14 days | As data is collected from subject record an analysis of this data will provide changes in hemoglobin levels |
Countries
Germany
Outcome results
None listed