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Intraarticular Fibrinogen Does Not Reduce Blood Loss in TKA: A Randomized Clinical Trial

  • Symposium: 2013 Knee Society Proceedings
  • Published:
Clinical Orthopaedics and Related Research®

Abstract

Background

Bleeding remains an ongoing concern after total knee arthroplasty (TKA). Intraarticular application of human fibrinogen with a topical thrombin has been described to stop diffuse bleeding in knee arthroplasty.

Questions/purposes

It was hypothesized that the use of human fibrinogen as a topical agent would result in a reduction of bleeding and transfusions required after TKA; secondary end points included comparison of early clinical results including pain scores and range of motion (ROM) at 6 weeks and complications after surgery.

Methods

Two hundred patients undergoing TKA were randomized into a double-blind clinical trial to receive either intraarticular fibrinogen 2 minutes before tourniquet release or no such treatment. Postoperative hemoglobin and hematocrit levels, drain output, and transfusion requirements were recorded and blood loss was calculated. Clinical outcomes and adverse events were tracked prospectively. Descriptive analysis was performed using a two-sample t-test.

Results

There were no differences in calculated blood loss between the fibrinogen and the control groups; the mean postoperative drain output was 780 ± 378 mL in the fibrinogen group compared with 673 ± 301 mL in the control group (p = 0.029), but the hemoglobin drop at Day 2 was 3.47 ± 1.53 g/L in the fibrinogen group and 3.84 ± 1.24 g/Ll in the control group (p = 0.051). There were no differences in in transfusions, early ROM, visual analog pain scores, or complications between the groups.

Conclusions

The use of fibrinogen in TKA did not lead to a significant reduction of blood loss or transfusions in primary TKA for osteoarthritis. Given the lack of benefits and the costs this procedure adds to TKA, its routine use cannot be justified during primary TKA for osteoarthritis.

Level of Evidence

Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

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Acknowledgments

We thank Ella Christoph for her support with submission of the manuscript.

Author information

Authors and Affiliations

  1. Department of Orthopedics and Rheumatology, University Hospital Marburg, Marburg, Germany

    Thomas Jan Heyse MD

  2. Adult Reconstruction & Joint Replacement Division, Hospital for Special Surgery, 535 E 70th Street, New York, NY, 10021, USA

    Steven B. Haas MD, Denise Drinkwater BA, Stephen Lyman PhD, Han Jo Kim MD, Barbara A. Kahn BS & Mark P. Figgie MD

Authors
  1. Thomas Jan Heyse MD
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  2. Steven B. Haas MD
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  3. Denise Drinkwater BA
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  4. Stephen Lyman PhD
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  5. Han Jo Kim MD
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  6. Barbara A. Kahn BS
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  7. Mark P. Figgie MD
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Corresponding author

Correspondence to Mark P. Figgie MD.

Additional information

The study was performed with Research Support from Ethicon, Inc (Somerville, NJ, USA) (USD 100,001–USD 1,000,000). One or more of the authors (TJH) is a consultant to and receives research support from Smith & Nephew (Memphis, TN, USA) (USD < 10,000). One or more of the authors (SBH) is a consultant to and receives royalties and research support from Smith & Nephew (USD > 1,000,001). One or more of the authors (HJK) is a board member to Medtronic, Inc (Minneapolis, MN, USA) (USD < 10,000). One or more of the authors (MPF) has stock in Mekanika (Boca Raton, FL, USA) (USD < 10,000).

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research editors and board members are on file with the publication and can be viewed on request.

Clinical Orthopaedics and Related Research neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA-approval status, of any drug or device prior to clinical use.

Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.

This work was performed at the Hospital for Special Surgery, New York, NY, USA.

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Heyse, T.J., Haas, S.B., Drinkwater, D. et al. Intraarticular Fibrinogen Does Not Reduce Blood Loss in TKA: A Randomized Clinical Trial. Clin Orthop Relat Res 472, 272–276 (2014). https://doi.org/10.1007/s11999-013-3036-1

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  • DOI: https://doi.org/10.1007/s11999-013-3036-1

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