- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02196415
Three-Dimensional Hindfoot Alignment Measurements Based On Biplanar Radiographs: Prospective Clinical Feasibility Study
- 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:
- Evaluation of technical feasibility of 3D hindfoot alignment measurements based on biplanar radiographs.
- Reproduction of superior interreader agreement of measurements based on biplanar radiographs compared to measurements on conventional radiographs.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8008
- Radiology Department, Balgrist University Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- Prior surgery, prior fracture, children and adolescents younger than the age of 20 years, known pregnancy.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biplanar radiography and 3D reconstruction of hindfoot
Time Frame: The measurement is performed immediately after image acquisition.
|
Hindfoot alignment is measured between the tibial axis and the calcaneal axis in degrees. Measurement on standard radiographs and biplanar radiographs are then compared. |
The measurement is performed immediately after image acquisition.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Florian M Buck, MD, Balgrist University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KEK-ZH-Nr. 2013-0459
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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