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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02427711
Enrollment
60
Registered
2015-04-28
Start date
2013-10-31
Completion date
2015-08-31
Last updated
2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Blood Loss

Keywords

Reduction of blood loss for revisions of knee arthroplasty, blood transfusions, Readmission, Bipolar sealer

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.

Interventions

DEVICEBipolar sealer

Prospective trial with Aquamantys for surgical skin and capsula incision w a retrospective control group using a conventional scalpel skin and capsula incision.

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Age below 18.

Design outcomes

Primary

MeasureTime frame
Estimated blood loss2nd postoperative morning

Secondary

MeasureTime frame
Blood loss1st. postoperative morning
Blood transfusionwhile hospitalized expected 5 days.
Readmission90 days after surgery

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026