Reduced Total Blood Loss and Blood Transfusion in Non-Septic Revision Knee Arthroplasty Using a Bipolar Sealer
NCT ID: NCT02427711
Last Updated: 2015-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2013-10-31
2015-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Bipolar sealer
Prospective use of bipolar sealer for skin and knee capsule incision revisions of non-septic knee arthroplasty.
Bipolar sealer
Prospective trial with Aquamantys for surgical skin and capsula incision w a retrospective control group using a conventional scalpel skin and capsula incision.
Scalpel
Conventional surgical incision with scalpel - data extracted from a retrospective group.
Bipolar sealer
Prospective trial with Aquamantys for surgical skin and capsula incision w a retrospective control group using a conventional scalpel skin and capsula incision.
Interventions
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Bipolar sealer
Prospective trial with Aquamantys for surgical skin and capsula incision w a retrospective control group using a conventional scalpel skin and capsula incision.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Musk speak and understand Danish
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Christian Skovgaard Nielsen
MD
Locations
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Hvidovre University Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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HVH-2013-037
Identifier Type: -
Identifier Source: org_study_id
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