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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASEPTIC Revision TKA & Aquamantys System | Active Comparator | 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. |
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| SEPTIC Revision TKA & Aquamantys System | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquamantys System | Procedure | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin and hematocrit from baseline (pre-op) | As data is collected from subject record an analysis of this data will provide changes in hemoglobin levels | 14 days |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Palaniswamy Vijay, PhD | Medtronic Surgical Technologies | Study Director |
| Joachim Singer, Dr.med. | Orthopädische Klinik Markgröningen gGmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopädische Klinik Markgröningen gGmbH | Markgröningen | 71706 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9973048 | Background | Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002. | |
| 20145794 | Background | Marulanda GA, Krebs VE, Bierbaum BE, Goldberg VM, Ries M, Ulrich SD, Seyler TM, Mont MA. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2009 Dec;38(12):E179-83. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 16525984 | Background | Marulanda GA, Ragland PS, Seyler TM, Mont MA. Reductions in blood loss with use of a bipolar sealer for hemostasis in primary total knee arthroplasty. Surg Technol Int. 2005;14:281-6. |
| 19675727 | Background | Pfeiffer M, Brautigam H, Draws D, Sigg A. A new bipolar blood sealing system embedded in perioperative strategies vs. a conventional regimen for total knee arthroplasty: results of a matched-pair study. Ger Med Sci. 2005 Dec 13;3:Doc10. |
| 17570284 | Background | Rosenberg AG. Reducing blood loss in total joint surgery with a saline-coupled bipolar sealing technology. J Arthroplasty. 2007 Jun;22(4 Suppl 1):82-5. doi: 10.1016/j.arth.2007.02.018. |