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

Primary Purpose

Total Blood Loss

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bipolar sealer
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Blood Loss focused on measuring Reduction of blood loss for revisions of knee arthroplasty, blood transfusions, Readmission, Bipolar sealer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Age below 18.

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bipolar sealer

Scalpel

Arm Description

Prospective use of bipolar sealer for skin and knee capsule incision revisions of non-septic knee arthroplasty.

Conventional surgical incision with scalpel - data extracted from a retrospective group.

Outcomes

Primary Outcome Measures

Estimated blood loss

Secondary Outcome Measures

Blood loss
Blood transfusion
Readmission

Full Information

First Posted
April 20, 2015
Last Updated
August 13, 2015
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02427711
Brief Title
Reduced Total Blood Loss and Blood Transfusion in Non-Septic Revision Knee Arthroplasty Using a Bipolar Sealer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Blood Loss
Keywords
Reduction of blood loss for revisions of knee arthroplasty, blood transfusions, Readmission, Bipolar sealer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bipolar sealer
Arm Type
Active Comparator
Arm Description
Prospective use of bipolar sealer for skin and knee capsule incision revisions of non-septic knee arthroplasty.
Arm Title
Scalpel
Arm Type
Placebo Comparator
Arm Description
Conventional surgical incision with scalpel - data extracted from a retrospective group.
Intervention Type
Device
Intervention Name(s)
Bipolar sealer
Other Intervention Name(s)
Aquamantys
Intervention Description
Prospective trial with Aquamantys for surgical skin and capsula incision w a retrospective control group using a conventional scalpel skin and capsula incision.
Primary Outcome Measure Information:
Title
Estimated blood loss
Time Frame
2nd postoperative morning
Secondary Outcome Measure Information:
Title
Blood loss
Time Frame
1st. postoperative morning
Title
Blood transfusion
Time Frame
while hospitalized expected 5 days.
Title
Readmission
Time Frame
90 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing Non septic knee-arthroplasty revision. Musk speak and understand Danish Exclusion Criteria: Age below 18.
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
Country
Denmark

12. IPD Sharing Statement

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

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