Clinical Trial: Reduced Total Blood Loss and Blood Transfusion in Non-Septic Revision Knee Arthroplasty Using a Bipolar Sealer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Reduced Total Blood Loss and Blood Transfusion in Non-Septic Revision Knee Arthroplasty Using a Bipolar Sealer - A Prospective Cohort Study With Retrospective Controls

Brief Summary: To investigate if the use of a bipolar sealer for skin and capsula incision results in decreased total blood loss and/or less blood transfusion in non-septic knee arthroplasty.

Detailed Summary:

In patients undergoing primary total knee arthroplasty, perioperative anemia is highly prevalent. In a systematic review, preoperative anemia was found in 24 +/- 9% and postoperative anemia in 51% +/- 10%. Perioperative anemia was associated with a blood transfusion rate of 45 +/- 25%, postoperative infections, poorer physical functioning and recovery, and increased length of hospital stay (LOS) and mortality. Although the best transfusion trigger in elective patients remains unknown, restrictive transfusion protocols are recommended and avoidance of blood transfusion if possible.

The only non-systemic modality capable of reducing blood loss before it occurs is a bipolar sealer (Aquamantys). By pre-incisional treatment of the soft tissue, bleeding (and potentially total blood loss and transfusion) is reduced without tissue charring.

Previously studies on the use of Aquamantys in primary knee arthroplasty have had various outcomes, the most recent being negative while the former 3 were positive regarding reduction in blood loss, drop in hgb and transfusions. No published date exist on potential outcomes in revision knee arthroplasty where blood loss and transfusion needs exceeds that of primary total knee arthroplasty by far. Aquamantys hence would theoretically benefit the most in a revision setting without the use of a tourniquet - and would be an interesting modality in modern contemporary fast-track revision if shown effective despite/on top of the use of additional blood saving modalities. The present study is therefore motivated by investigating this aspect.


Sponsor: Hvidovre University Hospital

Current Primary Outcome: Estimated blood loss [ Time Frame: 2nd postoperative morning ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood loss [ Time Frame: 1st. postoperative morning ]
  • Blood transfusion [ Time Frame: while hospitalized expected 5 days. ]
  • Readmission [ Time Frame: 90 days after surgery ]


Original Secondary Outcome: Same as current

Information By: Hvidovre University Hospital

Dates:
Date Received: April 20, 2015
Date Started: October 2013
Date Completion:
Last Updated: August 13, 2015
Last Verified: April 2015