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Basic Methods Handbook for Clinical Orthopaedic Research pp 507–513Cite as

Reporting Complications in Orthopaedic Trials

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Abstract

Complications in orthopaedic trials are an essential source of information. They may terminate unsuccessful treatment strategies, help to identify potential for development and form the basis for shared decision-making with patients. Therefore, anticipated complications/adverse events should be listed in all study protocols with clear and objective definitions along with appropriate scientific references. In addition, the normal course of healing and rehabilitation including an evidence-based range should be defined. For each complication, a minimum set of information should be documented due to the regulations to allow clinically meaningful evaluation and reporting. It is necessary to follow up a complication until it is resolved. An independent Complication Review Board should review and analyse all information about potential orthopaedic complications.

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Author information

Authors and Affiliations

  1. Goldhahn GmbH, Baden, Switzerland

    S. Goldhahn

  2. Department of Rehabilitation Science, Osaka Health Science University, Osaka, Japan

    Norimasa Nakamura

  3. Institute for Translational Medicine, ETH Zurich, Zurich, Switzerland

    J. Goldhahn

Authors
  1. S. Goldhahn
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  2. Norimasa Nakamura
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  3. J. Goldhahn
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Corresponding author

Correspondence to S. Goldhahn .

Editor information

Editors and Affiliations

  1. UPMC Rooney Sports Complex, University of Pittsburgh, Pittsburgh, PA, USA

    Volker Musahl

  2. Department of Orthopaedics, Sahlgrenska Academy, Gothenburg University, Sahlgrenska University Hospital, Gothenburg, Sweden

    Jón Karlsson

  3. Department of Orthopaedic Surgery and Traumatology, Kantonsspital Baselland (Bruderholz, Laufen und Liestal), Bruderholz, Switzerland

    Michael T. Hirschmann

  4. McMaster University, Hamilton, ON, Canada

    Olufemi R. Ayeni

  5. Hospital for Special Surgery, New York, NY, USA

    Robert G. Marx

  6. Department of Orthopaedic Surgery, NorthShore University HealthSystem, Evanston, IL, USA

    Jason L. Koh

  7. Institute for Medical Science in Sports, Osaka Health Science University, Osaka, Japan

    Norimasa Nakamura

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Goldhahn, S., Nakamura, N., Goldhahn, J. (2019). Reporting Complications in Orthopaedic Trials. In: Musahl, V., et al. Basic Methods Handbook for Clinical Orthopaedic Research. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-58254-1_49

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  • DOI: https://doi.org/10.1007/978-3-662-58254-1_49

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  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-662-58253-4

  • Online ISBN: 978-3-662-58254-1

  • eBook Packages: MedicineMedicine (R0)

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