Clinical trial NCT02266407: Surgical / Economic Effect of the Aquamantys System in Blood Management for Aseptic and Septic Revision TKA
Official title: The Surgical and Economic Effect of the Aquamantys System in Blood Management During and Following Aseptic and Septic Revision TKA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection of Total Knee Joint Prosthesis
Aseptic Loosening of Prosthetic Joint
Keywords: Revision TKA
Septic
Aseptic
Transfusion
Blood Loss
Lead sponsor: Medtronic Surgical Technologies
Sponsor class: INDUSTRY
First posted: 2014-10-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Loss and Post-Operative Transfusion Rate
timeFrame: 14 days
Secondary outcomes:
measure: Operative room and total hospital costs
timeFrame: 14 days
Other outcomes:
measure: Change in hemoglobin and hematocrit from baseline (pre-op)
timeFrame: 14 days
Locations:
city: Markgröningen
country: Germany
facility: Orthopädische Klinik Markgröningen gGmbH
Study officials:
affiliation: Medtronic Surgical Technologies
name: Palaniswamy Vijay, PhD
role: STUDY_DIRECTOR
affiliation: Orthopädische Klinik Markgröningen gGmbH
name: Joachim Singer, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.