title: Assessment of Fracture Repair.
abstract: Assessment of fracture union is a critical concept in clinical orthopaedics; however, there is no established "gold standard" for fracture healing. This review provides an overview of the problems related to the assessment of fracture healing, examines currently available tools to determine union, discusses the role of functional outcomes in the assessment of fracture healing, and finally evaluates healing outcome measures as they pertain to fracture trials. Because there is no universally accepted method to determine fracture healing, orthopaedic surgeons must rely on a range of tools that can include: radiographic assessment, mechanical assessment, serologic markers, and clinical evaluation (including functional outcomes). When used in conjunction, these tools can help to improve the sensitivity and specificity of determining fracture union. This is furthermore relevant when conducting fracture healing trials, for which there is little consensus between surgeons or the Food and Drug Administration as to optimal study endpoints. Such studies should therefore include a composite outcome measure consisting of radiographic and functional assessments to increase the quality and consistency of fracture healing trials.
authors.affiliation: *Division of Orthopaedic Surgery, Department of Surgery, St. Michael's Hospital, Toronto, ON, Canada; †Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON, Canada; ‡Institute of Medical Science, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; §Boston University Medical Center, Boston, MA; ‖University of Toronto, Toronto, ON, Canada; ¶Orthopaedic Trauma Institute, Department of Orthopaedic Surgery, University of California, San Francisco and San Francisco General Hospital, San Francisco, CA; **Department of Epidemiology and Biostatistics, University of California, San Francisco and San Francisco General Hospital, San Francisco, CA; and ††Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, MD.
authors.forename: Gillian E
authors.initials: GE
authors.lastname: Cook
authors.forename: Brent D
authors.initials: BD
authors.lastname: Bates
authors.forename: Paul
authors.initials: P
authors.lastname: Tornetta
authors.forename: Michael D
authors.initials: MD
authors.lastname: McKee
authors.forename: Saam
authors.initials: S
authors.lastname: Morshed
authors.forename: Gerard P
authors.initials: GP
authors.lastname: Slobogean
authors.forename: Emil H
authors.initials: EH
authors.lastname: Schemitsch
mesh_terms: D015415:Biomarkers / Q000097:blood; D017102:Fracture Healing; D050723:Fractures, Bone / Q000097:blood / Q000175:diagnosis* / Q000628:therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010808:Physical Examination / Q000379:methods*; D011857:Radiographic Image Interpretation, Computer-Assisted / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers