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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Christian Skovgaard Nielsen, Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT02427711

First received: April 20, 2015

Last updated: August 13, 2015

Last verified: April 2015

History of Changes

Purpose

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.

Condition	Intervention
Total Blood Loss	Device: Bipolar sealer


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Knee Replacement

U.S. FDA Resources

Further study details as provided by Christian Skovgaard Nielsen, Hvidovre University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	60
Study Start Date:	October 2013
Study Completion Date:	August 2015
Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Bipolar sealer Prospective use of bipolar sealer for skin and knee capsule incision revisions of non-septic knee arthroplasty.	Device: 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 Name: Aquamantys
Placebo Comparator: Scalpel Conventional surgical incision with scalpel - data extracted from a retrospective group.	Device: 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 Name: Aquamantys

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Age below 18.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02427711

Locations


Denmark
Hvidovre University Hospital
Hvidovre, Denmark

Sponsors and Collaborators

Hvidovre University Hospital

More Information


Responsible Party:	Christian Skovgaard Nielsen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT02427711 History of Changes
Other Study ID Numbers:	HVH-2013-037
Study First Received:	April 20, 2015
Last Updated:	August 13, 2015

Keywords provided by Christian Skovgaard Nielsen, Hvidovre University Hospital:


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

Additional relevant MeSH terms:


Hemorrhage Exsanguination Pathologic Processes

ClinicalTrials.gov processed this record on July 13, 2017

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