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CompletedNCT02196415Updated Oct 2, 2018

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

An observational study in Congenital Medial Deviation, sponsored by Balgrist University Hospital. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-02.

Sponsored by Balgrist University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

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.
Read the detailed description

Additional information to the brief summary:

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:

  • Inclusion: All patients referred for hindfoot alignment radiographs. These are all adults having suffered severe trauma or suffering from osteoarthrosis of the ankle joint. No inclusion of vulnerable participants.
  • Exclusion criteria: Prior surgery, prior fracture, children and adolescents younger than the age of 20 years, known pregnancy.

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

02

Conditions studied

  • Congenital Medial Deviation

Keywords

  • Hindfoot Alignment
  • Rearfoot
  • Malalignment
  • biplanar radiography
  • 3D measurement
03

In context

Lead sponsor

Balgrist University Hospital is the lead sponsor of 80 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with clinically suspected hindfoot malalignment

Inclusion criteria

  • All patients referred for hindfoot alignment radiographs. These are all adults having suffered severe trauma or suffering from osteoarthrosis of the ankle joint. No inclusion of vulnerable participants.

Exclusion criteria

Exclusion Criteria:

  • Prior surgery, prior fracture, children and adolescents younger than the age of 20 years, known pregnancy.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • DeviceBiplanar Radiography

    standard biplanar radiography of the foot

    Also known as: EOS low-dose biplanar radiography scanner

06

What researchers measure

Primary outcomes

  1. Biplanar radiography and 3D reconstruction of hindfoot

    Hindfoot alignment is measured between the tibial axis and the calcaneal axis in degrees. Measurement on standard radiographs and biplanar radiographs are then compared.

    Time frame: The measurement is performed immediately after image acquisition.

07

Study locations

1 site
  • Radiology Department, Balgrist University Clinic
    Zurich, ZH 8008, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02196415
Lead sponsor
Balgrist University Hospital
Responsible party
Sponsor
First posted
Jul 22, 2014
Start date
Jul 2014
Primary completion
Dec 1, 2017
Completion
Dec 1, 2017
Last update
Oct 2, 2018

Study contacts

Florian M Buck, MD
principal investigator · Balgrist University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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