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Reporting Complications in Orthopaedic Trials

  • S. GoldhahnEmail author
  • Norimasa Nakamura
  • J. Goldhahn
Chapter

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.

References

  1. 1.
    Carlesso LC, MacDermid JC, Santaguida LP. Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. J Orthop Sports Phys Ther. 2010;40(8):455–63.CrossRefGoogle Scholar
  2. 2.
    Corrales LA, Morshed S, Bhandari M, Miclau T III. Variability in the assessment of fracture-healing in orthopaedic trauma studies. J Bone Joint Surg Am. 2008;90(9):1862–8.CrossRefGoogle Scholar
  3. 3.
    Davis BJ, Roberts PJ, Moorcroft CI, Brown MF, Thomas PB, Wade RH. Reliability of radiographs in defining union of internally fixed fractures. Injury. 2004;35(6):557–61.CrossRefGoogle Scholar
  4. 4.
    Goldhahn S, Kralinger F, Rikli D, Marent M, Goldhahn J. Does osteoporosis increase complication risk in surgical fracture treatment? A protocol combining new endpoints for two prospective multicentre open cohort studies. BMC Musculoskelet Disord. 2010;11:256.CrossRefGoogle Scholar
  5. 5.
    Goldhahn S, Sawaguchi T, Audige L, Mundi R, Hanson B, Bhandari M, Goldhahn J. Complication reporting in orthopaedic trials. A systematic review of randomized controlled trials. J Bone Joint Surg Am. 2009;91(8):1847–53.CrossRefGoogle Scholar
  6. 6.
    Hutchinson D, editor. The Trial Investigator’s GCP Handbook: a practical guide to ICH requirements. Richmond: Brookwood Medical Publications; 1997.Google Scholar
  7. 7.
    ISO. ISO_14155:2011(E). Clinical investigation of medical devices for human subjects - Good clinical practice. International Standard Organization; 2011. p. 1–66.Google Scholar
  8. 8.
    Morshed S, Corrales L, Genant H, Miclau T III. Outcome assessment in clinical trials of fracture-healing. J Bone Joint Surg Am. 2008;90(Suppl 1):62–7.CrossRefGoogle Scholar
  9. 9.
    USFDA. Guidance for clinical trial sponsors. Establishment and operation of clinical trial data monitoring committees. CBER; 2006. p. 1–34.Google Scholar

Copyright information

© ISAKOS 2019

Authors and Affiliations

  1. 1.Goldhahn GmbHBadenSwitzerland
  2. 2.Department of Rehabilitation ScienceOsaka Health Science UniversityOsakaJapan
  3. 3.Institute for Translational MedicineETH ZurichZurichSwitzerland

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