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

Not Applicable

Completed

• Conditions: Total Blood Loss
• Interventions: Device: Bipolar sealer

• Registration Number: NCT02427711
• Lead Sponsor: Hvidovre University Hospital

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 Description

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.

Study Timeline

• Study Start: 2013-10
• Status Verified: 2015-04
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-28
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-13
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients undergoing Non septic knee-arthroplasty revision.
• Musk speak and understand Danish

Exclusion Criteria

• Age below 18.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Scalpel	Bipolar sealer	Conventional surgical incision with scalpel - data extracted from a retrospective group.
Bipolar sealer	Bipolar sealer	Prospective use of bipolar sealer for skin and knee capsule incision revisions of non-septic knee arthroplasty.

Primary Outcome Measures

Name	Time	Method
Estimated blood loss	2nd postoperative morning

Secondary Outcome Measures

Name	Time	Method
Readmission	90 days after surgery
Blood loss	1st. postoperative morning
Blood transfusion	while hospitalized expected 5 days.

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark