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Outcome(s): Hindfoot alignment measurement on standard radiographs and biplanar radiographs. The hindfoot angle is measured between the tibial axis and the calcaneal axis in degrees. Measurement results on plain films and based on 3D reconstructions will be compared.
Inclusion/Exclusion criteria:
Measurements and Procedures: Measurement of hindfoot alignment based on conventional radiographs and based on biplanar radiographs by two independent radiologists. Comparison of measurement results (paired-t-test, Wilcoxon signed-rank test) and calculation of interreader agreement (Intraclass correlation coefficient).
Study Product / Intervention: EOS low-dose biplanar x-ray scanner, EOS imaging, Paris, France One scan of the ankle joint to obtain an antero-posterior and lateral view.
Control Intervention: Conventional x-rays of the ankle joint (a.p., lateral, long axial or hindfoot alignment view) as referred from the clinician for treatment planning.
Number of Participants: 50 adults Based on a power analysis we think that this number of patients will enable reliable results. Because we do not know how big the differences between the measurements on standard radiographs and measurements on biplanar radiographs will be it is very difficult to perform a reasonable power analysis. In prior studies comparing torsion measurements on biplanar radiographs with CT measurements we were able to produce reliable results with the same number of patients.
Study Schedule:
First-Participant-In: June 2014 Last-Participant-Out: May 2015
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Data sourced from clinicaltrials.gov
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