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Three-Dimensional Hindfoot Alignment Measurements Based On Biplanar Radiographs: Prospective Clinical Feasibility Study

NCT02196415 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2018-10-02

No results posted yet for this study

Summary

* The measurement of hindfoot alignment is a technical challenge.
* Today, hindfoot alignment is typically measured on hindfoot alignment view radiographs or long axial view radiographs. Measurements on both types of radiographs are hampered by technical shortcomings such as minimal rotational misplacement of the foot at the time of image acquisition. In previous publications our study groups demonstrated substantial measurement errors due to these shortcomings as well as bad interreader agreement.
* Hindfoot alignment measurement is feasible on MR images but hampered by the non-weight-bearing position of the patient and therefore not suited for pre-treatment evaluation.
* In an ex vivo study using plastic phantoms of a foot our research group could demonstrate superior interreader agreement and complete correction for foot misplacement at the time of image acquisition using a 3D secondary measurement technique based on biplanar low dose radiographs.
* Image acquisition using biplanar low dose radiographs is associated with a substantial reduction (about 1/7) of radiation dose applied to the patient compared to standard radiographs.
* Therefore the question arises if these excellent ex vivo results can be confirmed in a prospective clinical study.

Objectives:

1. Evaluation of technical feasibility of 3D hindfoot alignment measurements based on biplanar radiographs.
2. Reproduction of superior interreader agreement of measurements based on biplanar radiographs compared to measurements on conventional radiographs.

Conditions

  • Congenital Medial Deviation

Interventions

DEVICE

Biplanar Radiography

standard biplanar radiography of the foot

Sponsors & Collaborators

  • Balgrist University Hospital

    lead OTHER

Principal Investigators

  • Florian M Buck, MD · Balgrist University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-12-01
Completion
2017-12-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02196415 on ClinicalTrials.gov