0
Scientific Articles   |    
The Efficacy of a Thrombin-Based Hemostatic Agent in Unilateral Total Knee ArthroplastyA Randomized Controlled Trial
Han Jo Kim, MD1; M. Robson Fraser, MD1; Barbara Kahn, NP1; Stephen Lyman, PhD1; Mark P. Figgie, MD1
1 Hospital for Special Surgery, 535 East 70th Street, New York, NY, 10021. E-mail address for M.P. Figgie: figgiem@hss.edu
View Disclosures and Other Information
Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

  • Disclosure statement for author(s): PDF

Hospital for Special Surgery, 535 East 70th Street, New York, NY, 10021. E-mail address for M.P. Figgie: figgiem@hss.edu
Investigation performed at the Hospital for Special Surgery, New York, NY
This article was chosen to appear electronically on May 23, 2012, before publication of the final, definitive version.

Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Jul 03;94(13):1160-1165. doi: 10.2106/JBJS.K.00531
5 Recommendations (Recommend) | 3 Comments | Saved by 3 Users Save Case

Abstract

Introduction: 

Blood loss following total knee arthroplasty can lead to substantial morbidity and the need for blood transfusions. Hemostatic agents have been used to minimize blood loss and to decrease transfusion rates. Floseal is a thrombin-based hemostatic agent with unknown efficacy for achieving these goals in patients undergoing total knee arthroplasty.

Methods: 

We performed a prospective randomized controlled trial on the use of Floseal in patients undergoing total knee arthroplasty, with the primary end point being blood loss as measured through drain output. Demographic characteristics, operative side, diagnosis, intraoperative details, implant choice, hospital course, laboratory values, visual analog scale pain scores, knee range of motion, adverse events, transfusion rates, and deviations from protocol were recorded.

Results: 

A total of 196 patients were enrolled, with ninety-seven patients being randomized to the Floseal group and ninety-nine patients being randomized to the control group. There were no significant differences between the Floseal and control groups in terms of drain output at twenty-four hours (711 compared with 702 mL; p = 0.823). No differences were noted between the groups in terms of operative side, diagnosis, intraoperative details, implant choice, hospital course, laboratory values, visual analog scale pain scores, knee range of motion, or transfusion rates. Complications occurred infrequently. In the acute postoperative period, there were two cases of cellulitis (one in each group), two deep venous thromboses (one in each group), and one paralytic ileus (in the control group), all of which resolved with nonoperative measures. At the six-week follow-up, one patient in the Floseal group had died from a cause unrelated to surgery, two patients (one in each group) had suture abscesses with cellulitis that resolved with postoperative antibiotics, and four patients (two in each group) underwent knee manipulation under anesthesia to achieve improved knee motion. With the numbers available, there was no significant association between Floseal use and the occurrence of these adverse events.

Conclusions: 

The present study showed that Floseal had no demonstrable effect on blood loss as measured through drain output following total knee arthroplasty. There were also no notable adverse events associated with its use. The usefulness of Floseal as a hemostatic agent in total knee arthroplasty remains unclear.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Figures in this Article
    Sign In to Your Personal ProfileSign In To Access Full Content
    Not a Subscriber?
    Get online access for 30 days for $35
    New to JBJS?
    Sign up for a full subscription to both the print and online editions
    Register for a FREE limited account to get full access to all CME activities, to comment on public articles, or to sign up for alerts.
    Register for a FREE limited account to get full access to all CME activities
    Have a subscription to the print edition?
    Current subscribers to The Journal of Bone & Joint Surgery in either the print or quarterly DVD formats receive free online access to JBJS.org.
    Forgot your password?
    Enter your username and email address. We'll send you a reminder to the email address on record.

     
    Forgot your username or need assistance? Please contact customer service at subs@jbjs.org. If your access is provided
    by your institution, please contact you librarian or administrator for username and password information. Institutional
    administrators, to reset your institution's master username or password, please contact subs@jbjs.org

    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
    CME Activities Associated with This Article
    Submit a Comment
    Please read the other comments before you post yours. Contributors must reveal any conflict of interest.
    Comments are moderated and will appear on the site at the discretion of JBJS editorial staff.

    * = Required Field
    (if multiple authors, separate names by comma)
    Example: John Doe





    Related Content
    The Journal of Bone & Joint Surgery
    JBJS Case Connector
    Topic Collections
    Related Audio and Videos
    Clinical Trials
    Readers of This Also Read...
    JBJS Jobs
    04/16/2014
    Ohio - OhioHealth Research and Innovation Institute (OHRI)
    04/16/2014
    Georgia - Choice Care Occupational Medicine & Orthopaedics
    02/05/2014
    Oregon - The Center - Orthopedic and Neurosurgical Care and Research