CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Aquamantys Systemprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02266407
NCT02266407N/ACompleted
CompareCT.gov

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

Medtronic Surgical Technologies·interventional·Posted Oct 17, 2014·Updated Feb 27, 2020

In Brief

A clinical study evaluating Aquamantys System for Infection of Total Knee Joint Prosthesis and Aseptic Loosening of Prosthetic Joint. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection of Total Knee Joint Prosthesis, Aseptic Loosening of Prosthetic Joint
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2014
Enrollment StartJun 1, 2012
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.7 years ago

Interventions

Aquamantys Systemprocedure

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.